cyrilzakka/clinical-trials huggingface dataset:
Effect of Simvastatin Withdrawal on Ocular Endothelial Function

Statins are drugs representing the most commonly prescribed medication for the treatment of hypercholesterolemia. In a recently published study, discontinuation of statin therapy in patients after acute myocardial infarction was associated with a higher all-cause mortality (hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence suggests that statins also have vasoactive properties by up-regulating endothelial nitric oxide synthase (eNOS) with positive effects on endothelial function. Experiments with flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on endothelial function but also revealed that withdrawal of statin treatment transiently worsens endothelial function, independently of serum cholesterol levels.

Consequently, this placebo controlled Phase IV crossover study wants to assess changes of endothelial function in terms of flicker induced vasodilatation before and during statin therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced vasodilatation and retinal oxygen saturation will be measured with the Dynamic Vessel Analyzer system by Imedos at baseline, in the 4th week of simvastatin or placebo intake as well as 3, 7 and 14 days after the end of intake.


Eligibility Criteria:
Inclusion Criteria:

Informed consent for participation

* Men and women aged between 18 and 45 years, non-smokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Systolic blood pressure \< 140 mmHg, diastolic blood pressure \< 90 mmHg
* Normal ophthalmic findings, ametropia less than 6 diopters

Exclusion Criteria:

* History or presence of ocular disease
* Ametropy ≥ 6 dpt
* Previous or current treatment with statins
* Treatment with any drug in the 3 weeks preceding the first study day
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Participation in a clinical trial in the 3 weeks preceding the first study day
* Blood donation during the 3 weeks preceding the first study day
* History or family history of epilepsy
* History or presence of myopathy, renal failure or elevation of creatine kinase (CK) above normal levels
* History or presence of hepatic dysfunction, including increase of liver enzymes
* Abuse of alcoholic beverages
* Pregnancy
18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound

The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.

1. To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy.
2. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 20 to 80 years
2. women who have localized findings on mammography and / or ultrasound and will receive biopsy.
3. The lesions on the conventional imaging measure \>=1cm
4. WBC count \>=3000/L, or platelet\>=75,000/L
5. Liver function, AST or ALT \< 78 U/L
6. Renal function, Creatinine \< 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.

Exclusion Criteria:

1. Pregnant women or who are planning to be pregnant.
2. Known cancers in other organs.
3. Women who are not able to cooperate with the PET/CT examination.
Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery

This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.

Thyroid cancer is a most common solid organ cancer in South Korea, according to 2014 statistics from Korea Central Cancer Registry.

The most important treatment of thyroid cancer is a surgery. Principle of thyroid cancer surgery is cancer-involved thyroid gland resection and central/lateral compartment of neck node dissection.

Part of surgical complications associated with neck lymph node dissection are seroma and chyle leakage. Incidence of seroma and chyle leakage have been reported as 4-5% and 1-7% in previous studies. Currently, there's no effective agents to prevent these complications.

"Polyglycolic Acid Mesh Sheet (NeoveilTM)" is a tissue strengthening repair agent which is prevent air or fluid leakage. It's effects were proven in various surgical field - prevent air leakage in lung surgery, reduce pancreatic fistula in pancreas surgery and so on. However, there's no result in thyroid cancer surgery.

This study will investigate the usability of NeoveilTM in thyroid cancer surgery and have the effect of preventing seroma and chyle leakage.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are between 20 and 70 years of age
* Patients who agreed to the study
* Patients undergoing thyroidectomy and cervical node dissection for thyroid cancer
* Patients without perithyroidal organ infiltration or distant metastasis
* Before the operation, bilateral vocal cord movement was normal
* Patients without significant abnormal findings in laboratory tests before surgery

Exclusion Criteria:

* Patients judged to be inadequate by the person in charge of clinical trial
* Aspirin, anti-platelet medication within 7 days of admission
* Uncontrolled hypertension, diabetes, chronic renal failure, coagulation disorders
* Cardiovascular disease (angina, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
* Drug abuse and alcohol abuse
* History of esophagus and airway diseases
* Patients who participated in other clinical trials within 30 days
* Patients who had previous history of neck irradiation or neck surgery
* Patients with a history of allergy to drugs
* For women, pregnant and lactating patients
Brief Online Help-seeking Barrier Reduction Intervention

Objective: Mental illness is a leading cause of disease burden; however, many barriers prevent people from seeking mental health services. Technological innovations may improve the ability to reach under-served populations by overcoming many existing barriers. The investigators evaluated a brief, automated risk assessment and intervention platform designed to increase the use of crisis resources provided to individuals who were online and in crisis. Hypothesis: The investigators hypothesized that individuals assigned to the intervention condition would report using crisis resources at higher rates than individuals in the control condition. Method: Participants, users of the digital mental health app Koko, were randomly assigned to treatment or control conditions upon accessing the app and were included in the study after their posts were identified by machine learning classifiers as signaling a current mental health crisis. Participants in the treatment condition received a brief Barrier Reduction Intervention (BRI) designed to increase the use of crisis service referrals provided on the app. Participants were followed-up several hours later to assess the use of crisis services.


Eligibility Criteria:
Inclusion Criteria:

* Participants identified as experiencing a mental health crisis by a hybrid human-machine computation system evaluating semantic content of posts made on digital platforms.

Exclusion Criteria:

* Participants who were not identified as experiencing a mental health crisis.
Assessment of Volume Status by Doppler US

Fluid are used to increase cardiac output (CO) and blood pressure in patients admitted to the intensive care unit (ICU) .Fluid is an important line of therapy that needed in shocked patient, hypovolemic and following surgery to correct the volume state and avoid acute kidney injury. However, excess fluid administration may be harmful leading itself to increase rates of acute kidney injury (AKI), prolonged days of mechanical ventilation and death . Excess fluid administration may increase right and left atrial pressure leading to congestion and edema.

Increasing cardiac output more than 15% following fluid administration was used as fluid responsiveness method by the Surviving Sepsis Campaign (SSC) guidelines. However, these strategies may promote over-resuscitation as most recommend continuing fluid administration until the patients are no longer VR. VR-based strategies do not assess elevations in right atrial pressure (RAP) or assess for venous congestion which could occur earlier.

The elevations of left atrial pressure can be seen clinically with hypoxia, cephalization on chest X-ray and B-lines on ultrasound resulting from pulmonary edema, while the elevation in right-sided pressure is much more difficult to detect.

It is possible that rightsided venous flow changes detect clinically important elevations in right atrial pressure that lead to venous congestion and end organ injury . Doppler flow patterns of hepatic veins (HV), portal vein (PV) and intra-renal veins (RV) are noninvasive and accurately identify early stages of right-sided venous congestion in patients who have cardiac dysfunction and congestive heart failure with elevated right atrial pressures . If HV, PV and RV can be validated as reliable measures of elevated RAP, such indicators might have utility in modulating fluid resuscitation in other critically ill patient populations.

Eligibility Criteria:
Inclusion Criteria:

* - Adult patients who admitted to critical care unit and intermediate critical care unit of Internal medicine department after obtaining consent.

Exclusion Criteria:

* 1- Children below 18 yr. 2- Patients could not be scanned within 24-h after ICU admission. 3- Patients with transplanted kidney or liver. 4- Patients with end stage renal disease.
Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

The investigators plan to conduct this randomized sham-controlled clinical trial to evaluate the efficacy and safety of electroacupuncture (EA), compared with sham electroacupuncture (SA) on women with mixed urinary incontinence (MUI).

MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. Electroacupuncture has been proved not inferior to pelvic floor muscle training plus solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

Eligibility Criteria:
Inclusion Criteria:

* Female, 35 to 75 years old
* Diagnosed as mixed urinary incontinence
* Positive in cough stress test
* Experiencing persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in baseline screening
* Sign the informed consent form

Exclusion Criteria:

* Diagnosed as simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence or neurogenic bladder, etc.
* Uncontrolled urinary tract infection with urinary pain and urge
* Urogenital system tumours and/or pelvic organ tumours
* Patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month
* History of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy; Patients have pelvic organ prolapse ≥ II degree
* Residual urine ≥ 100ml
* Uncontrolled diabetes mellitus and severe hypertension
* Diseases affecting lower urinary tract function
* Severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction
* Constrained or unable to complete movements like walking, going stairs up and down and running, etc.
* At pregnancy, breastfeeding or postpartum period for less than 12 months
* Cardiac pacemaker, metal allergy or strong fear of needle
* Patients have received acupuncture in the past 3 months
A Pilot Study to Assess the Follow-up of Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment

This is a pilot study assessing the role of the general practitioner in performing follow-up reviews on men who have recently completed radical radiotherapy for prostate cancer. This will be measured primarily by assessing any changes to the patient's health-related quality of life which will be evaluated by the completion of questionnaires by the participant at each review visit. The study aims to confirm that patient outcome is identical, independent of whether follow-up is performed by a specialist or the patient's General Practitioner.


Eligibility Criteria:
Inclusion Criteria:

* Men with a tumour T1-3 stage prostate cancer and have had radical radiotherapy with curative intent
* Are between six and twelve months post-treatment completion
* Have completed all treatment for prostate cancer (including hormonal deprivation therapy)
* Have no evidence of metastatic disease
* ECOG performance status of between 0-1
* Remains willing to comply with study requirements
* Has maintained contact with an individual general practitioner

Exclusion Criteria:

* Persistent complications resulting from treatment defined as a minimum Grade 3 treatment toxicity
* Unable to complete self-administered questionnaires
* Are currently enrolled in a study that requires specialist follow-up
* Life expectancy of less than 6 months
* Surgery to remove the prostate
* Evidence of biochemical failure
A Test of Neural Inertia in Humans With Xenon

The dual objectives of this study are to determine if the phenomenon of neural inertia is present in humans and to determine whether the order of neurocognitive function is invariant among anesthetic agents. This study will enroll 24 healthy volunteers, ages 20-40 years, who will receive xenon gas (concentrations ranging from 0% to 60%) delivered via inhaled route through the ENHANCER 3000.

This is a multimodal, nonrandomized study of healthy subjects. After meeting enrollment criteria, subjects will receive a baseline neurocognitive testing on a computer for 15 minutes and will then receive a wrist watch actigraphy device to record their rest/activity patterns over 8-14 days. On the study day (roughly two weeks later), repeat baseline neurocognitive testing will be performed after subjects are fitted with a high density EEG head cap. The actual intervention (delivery of inhaled xenon gas in stepwise increasing followed by decreasing doses) should occur over 2 hours along with verbal tests to assess the presence/absence of consciousness at each xenon concentration. Xenon doses have been chosen specifically to evaluate the point at which individuals lose and then regain consciousness. Doses are escalated up through those used in human anesthesiology (75%) that permit surgery. After exposure, serial neurocognitive testing will occur every 30 minutes for 3 hours post emergence. Subjects are discharged from the study's intervention day to home only upon reaching standard post-anesthesia care unit criteria (modified Aldrete score ≥9). A post-procedure follow up phone call will occur within 24 hours of anesthetic exposure to ensure that the subject remains well. The individual's involvement is completed upon returning the Actigraphy watch 1 week after the exposure day. The expected duration of subject participation is 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ages 20-40 years old
* American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. healthy)
* Body Mass Index \<30 kg/m2
* Easily visible uvula

Exclusion Criteria:

* Any physical signs that would suggest a difficult airway (e.g. mouth opening \<3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck)
* History of reactive airway disease
* Current or history of neuropsychiatric disorders
* History or current use of psychotropic medications,
* History or current obstructive sleep apnea
* Current or history of cardiovascular disease or arrhythmias,
* Current or history of chronic sleep disorders
* History of postoperative nausea/vomiting
* Family history of problems with anesthesia (including but not limited to malignant hyperthermia),
* Current or history of Motion sickness
* Current tobacco use
* Current pregnancy or currently breastfeeding
* Positive urine toxicology screen
* History of seizure disorder, head injury, or brain tumor
* Alcohol consumption greater than 12 drinks per week or more than 4 drinks on any single day
* Inability to provide informed consent
* Inability to achieve mask seal on intervention day
Comparison of the Effects of Protocols Applied After Surgical Extraction of Impacted Mandibular Third Molars

Following the surgical extraction of the most commonly impacted mandibular third molars, the first group was planned to receive methylprednisolone, the second group hyaluronic acid, the third group ozone therapy, the fourth group laser application, and the fifth group only the routine treatment protocol. The study comparatively evaluated the effectiveness of these five groups in preventing complications such as pain, edema, and trismus that may develop after impacted third molar surgery.

The mandibular third molars are the most commonly impacted teeth in the jaws, and their surgical extraction is a frequently performed procedure in oral and maxillofacial surgery clinics. Postoperative pain, trismus, and edema, particularly within the first 48 hours after surgery, significantly impair patients' quality of life. In addition to routinely prescribed medications, various postoperative treatment methods have been explored to minimize or control these complications. Some of the methods reported in the literature include corticosteroid administration, low-level laser therapy, hyaluronic acid application at the extraction site, and ozone therapy.

Corticosteroids exert their anti-inflammatory effects by inhibiting both the function and production of certain inflammatory cells. Therefore, they have been widely used for many years to reduce complications following impacted third molar surgery. Low-level laser therapy (LLLT) has anti-inflammatory and analgesic properties, as well as a biostimulatory effect that promotes wound healing. Ozone therapy, due to its antibacterial and anti-inflammatory properties, as well as its ability to accelerate epithelial healing, has been recognized in the literature as a modern, drug-free alternative for managing postoperative complications.

Hyaluronic acid (HA) is a member of the glycosaminoglycan family found in various body tissues. Due to its numerous advantages, including the promotion of wound healing, anti-inflammatory, bacteriostatic, and osteoinductive effects, it plays a crucial role in tissue healing and the prevention of postoperative sequelae.

This study comparatively evaluates the efficacy of low-level laser therapy, hyaluronic acid, ozone therapy, and methylprednisolone in preventing complications such as pain, edema, and trismus following impacted mandibular third molar surgery, with the aim of improving patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients classified as American Society of Anesthesiologists (ASA) Class I or II
* Age range of 18-35 years
* Individuals of both genders
* Horizontally impacted teeth with the same angulation according to Winter's classification

Exclusion Criteria:

* Patients with any pathological condition around the impacted tooth
* Pregnant or breastfeeding women
* Smokers
* Individuals with allergic reactions to the adjuvants or prescribed medications used in the study
* Surgical extraction procedures exceeding 30 minutes
Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study

Several measurements are used to evaluate hip dysplasia in hip ultrasound of children. Despite having being used since the 1980s, reliability studies have failed to find acceptable reliaiblity values for the gold standard ultrasound methods.

This study will evaluate three ultrasound measurement methodologies in a high quality controlled setting, to investigate the best achieveable reliability and agreement of the investigated measurements used in hip dysplasia diagnostics.

In DDH diagnostics, measurements of acetabular alpha angles and femoral head coverages (FHC), developed by Graf and Harcke/Terjesen respectively, have been gold standard since the 1980s. Despite their widespread use, the reliability of these measurements has been questioned due to the relative complexity of acquiring the necessary corIDrect frontal 2D plane or "standard plane". In the only meta-analysis of the reliability of ultrasound (US) metrics in dysplasia, the interrater reliability of the alpha angles was mediocre while the reliability of the FHC was poor. Critics of these findings however argue that the low reliability reported in studies are due to misinterpretation and misapplication of the Graf method.

The pubo-femoral distance (PFD) was proposed in 2013 as a new measurement for assessing DDH, while the reliability is reportedly higher than the gold standard US methods, it has never been directly compared to these.

This study aims to evaluate the inter- and intrarater reliability of Graf's alpha and beta angles, the FHC and PFD in children referred for hip US in a selective ultrasound screening program for DDH.

Eligibility Criteria:
Inclusion Criteria:

* Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.
* Children receiving follow-up ultrasound for previously diagnosed DDH

Exclusion Criteria:

* Children deemed too agitated to participate in hip US with double measurements by two radiologists.
Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD

Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)

IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France).

To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy.

Two questionnaires have been developed, their psychometric properties need to be studied.

The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.

Eligibility Criteria:
Inclusion Criteria:

* Patient member of the AFA Crohn RCH, and registered in the mailing list
* Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.

Exclusion Criteria:

- There were no non-inclusion criteria.