cyrilzakka/clinical-trials huggingface dataset:
Validation of the DyCare® Lynx System for Motion Analysis of the Wrist

This project is set to compare the wrist joint movement measurements of the DyCare® Lynx System with optoelectronic motion analysis using a marker system and infrared cameras.

A total of 10 healthy test persons will be subjected to both the DyCare® Lynx and the Vicon® measurements during standard movements as well as during activities of daily living. The wrist joint angles measured with both systems will be compared.

The accepted laboratory gold standards for human motion analysis are too over-elaborated for clinical use. The DyCare® Lynx system is user-friendly and has been proven reliable for motion evaluation of different joints, but not yet for the wrist.

Therefore, this project is set to compare the wrist joint movement measurements of the DyCare® Lynx System with optoelectronic motion analysis using a marker system and infrared cameras. DyCare® Lynx is based on two inertial sensors (DyTrack) capable of objectively measuring three dimensional joint movements in real time. Each inertial sensor includes an accelerometer, gyroscope and magnetometer and captures up to 1'000 samples per second. DyCare® Lynx is certified for measurements on the human musculoskeletal apparatus (EN ISO 13485:2003 Certificate No. 15185 - M), is CE marked and will only be applied to each participant for a few minutes during the measurements. The control measurements will be conducted using a Vicon® motion capture system in the Motion Analysis Laboratory of the Department of Plastic Surgery and Hand Surgery of the University Hospital of Zurich. The Vicon® system is equipped with 11 infrared cameras. The system is made for 'Life science application' and is approved as CE medical device. A total of 10 healthy test persons will be subjected to both the DyCare® Lynx and the Vicon® measurements during standard movements as well as during activities of daily living. The wrist joint angles measured with both systems will be compared, therefore limits of agreement, maximum difference and root mean squared difference will be calculated to quantify the deviation between methods. The standard error of measurements will be calculated to determine repeatability of the systems.

Eligibility Criteria:
Inclusion Criteria:

* 10 test persons with healthy right-dominant hands
* Test Persons older than 18 Years
* Test persons willing and able to give written informed consent to participate in the study

Exclusion Criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* German language barrier to understand instructions
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management

This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.

Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta.

However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis.

Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 40 years.
* Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.

Exclusion Criteria:

* Women with a bleeding disorder.
* History of known allergy to contrast media.
* Women with Impaired renal function.
* Emergency cesarean section.
* Women had severe attack of bleeding before the operation affecting patient's general condition.
* Women had previous four or more cesarean scars.
* If ultrasound (US) and magnetic resonance imaging (MRI) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents

A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.

Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study. Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Current primary diagnosis of bipolar I disorder, mania or mixed type
* Aged between 10 and 17 years
* Young Mania Rating Scale score greater than or equal to 20 at screening and baseline

Exclusion Criteria:

* Known or suspected history of substance dependence
* Significant risk for suicidal or violent behavior
* Received electroconvulsive treatment within 4 weeks of baseline
* Received a depot antipsychotic within 2 treatment cycle before baseline
* Is unable to swallow medication taken in the form of tablets
* Has a positive result for a urine drug screen done at baseline
* Known or suspected seizure disorder
* Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening
* Known or suspected history of hypersensitivity or intolerance to risperidone
* History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
FGF21 Can Help Predicting Arterial Stiffness Measured by Cardio-ankle Vascular Index in Renal Transplant Patients

Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event after renal transplantation. And remain a major cause of mortality. The major risk marker is arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall stiffness and can estimated the risk of atherosclerosis.

Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to study the association between CAVI and FGF-21 and their relations to various parameters that can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other traditional basic factors.

A total of 90 participants who underwent renal transplant were included in the study. The following measures were done and laboratory data were collected. CAVI, Ecchocariogram, Homocysteine, Hs-CRP, Carotid IMT, FGF-21, Medication after renal transplantation, incidence of cardiovascular disease correlation between categorical data was done by using Pearson's correlation test and multiple regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* renal transplant patients patients for more than 1 month

Exclusion Criteria:

* who had contraindication for CAVI
* current smoker
* eGFR \<15 ml/min/173
* cardiac arrthymia
Immune Spatial Features of Guselkumab Cutaneous Response

This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.

This is a one-arm, open-label study to examine the effect of Guselkumab . Guselkumab is a FDA-approved medication for the treatment of psoriasis. This study will examine how Guselkumab affects immune cells within scalp psoriasis lesions. Ten subjects with moderate to severe scalp psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with Guselkumab treatment response.

Eligibility Criteria:
Inclusion Criteria: possess a PSSI (psoriasis scalp severity index) of ≥12

Exclusion Criteria:

1. taking systemic immunosuppressives in the last 4 weeks
2. pregnancy
3. severe immunodeficiency (either from genetic or infectious causes).
4. tuberculosis or other active serious infection
5. active systemic malignancy.
6. breast-feeding
7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
8. Males who are trying to conceive

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Effectiveness and Safety Evaluation of Aqueduct 100-device

Evaluation of efficacy and safety of using Aqueduct -100 - Cervical Dilator Device, focusing on diagnostic or operative hysteroscopies.

There are predominantly two major dilatation techniques that are employed in dilating the cervix. The first technique uses expansible dry solid material, such as laminaria (seaweed) is inserted into the cervix in its dried stiff form. In the cervix it comes into contact with body fluids that cause the laminaria to swell and enlarge the cervical cavity. The second more widespread procedure, involves the use of series of solid, rod like instruments of graduated diameter used in serial fashion by the physician (Hegar dilators). The physician first inserts a rod like dilator and replaces it with the dilator of next higher diameter. This procedure continues until adequate dilatation occurs.

The Problem is that each of the above-mentioned methods has its shortcomings: the use of the laminaria method (rarely done) requires preliminary patient visit, for insertion of the laminaria rod and is extremely slow and typically involves often as much as 10-12 hours for a significant amount of dilatation to occur.

The use of rod-like instruments (Hegar) requires general or regional anesthesia, when local anesthetics are used, the patient nevertheless frequently experiences a great amount of discomfort from the procedure. The mechanical dilatation of the cervix demands a large amount of longitudinal force that may damage or even puncture the cervix and the uterus.

Aqueduct 100 is a catheter for use in dilating various body cavities and especially the human cervix. The device will enable continuous, fast and safe dilatation of the cervix to a pre-determined diameter as a pre-procedure to intrauterine surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Subjects, females, 18 years of age or older.
* Subjects undergoing diagnostic or operative hysteroscopies
* Subjects willing to sign informed consent form.

Exclusion Criteria:

* Subjects younger than 18 years of age
* Subjects unwilling to sign the informed consent form
* Pregnancy
Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.

A prospective detection and quantification of HR-HPV in patients with proven CIN1 will be performed. Relationship between HR-HPV initial viral load and the CIN1 persistence will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The women whose last one FCV of screening put in evidence a LIEBG of the neck of the womb having been confirmed by the colposcopie.
* The inclusive patients will be of more than 18 years old. All the patients will be profitable of a regime of Social Security.

Exclusion Criteria:

* The patients whose result of the colposcopie is clashing with that of the FCV of initial screening (normal collar, LIEHG or the other one).
* The patients having an antecedent of DREGS of the neck of the womb, that this one was or not handled
* The patients having had a hysterectomy.
* The patients incapable to receive the information enlightened on the progress and the objectives of the study
* The patients not having signed enlightened assent
Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion

A study that compares between Open TLIF and Minimally invasive TLIF regarding patients' functional status(Oswestry Disability index)as a primary outcome measure.

The first randomized controlled trial comparing minimally invasive TLIF and open TLIF.

Eligibility Criteria:
Inclusion Criteria:

* Adults more than 18 years of age and less than 65 years of age..
* Degenerative or isthmic spondylolithesis Grade 1,2 and 3.
* Recurrent Symptomatic recurrent lumbar disc prolapsed with or without evident neural compression.
* Single level pathology involving L2-3, L3-4, L4-5 and or L5-S1.
* Symptoms not responding to conservative treatment for at least 3 months.

Exclusion Criteria:

* Previous spinal fusion or instrumentation.
* Spinal tumours, infection and fractures.
* Patients with severe osteoporosis
* BMI more than 35.
* Non-ambulant patients and patients with severe preoperative neurological affection (Cauda Equina Syndrome)
* Patients not willing to participate in the study
The Effect of Eggs and Egg Products on Macular Pigment

Age-related macula degeneration (AMD, encompassing both dry and wet form), the late stage of Age-related maculopathy (ARM), is the leading cause of blindness in many developed countries in older persons (usually over 60 years of age). Visual compromise rises exponentially after the age of 70 with a 5-year incidence of around 1%. Studies have shown a possible protective effect of lutein on progression of AMD, where visual acuity improves after increased lutein intake. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years is over 50% with a 2.1-2.8% overall incidence in the study population.

Blue light hazard (excitation peak 440 nm) was shown to have a major impact on photoreceptor and RPE function inducing photochemical damage and cellular apoptosis, leading to retinal degeneration in an animal study. The current belief is that lutein accumulated in the macular region helps in the prevention of blindness by absorbing blue light and protecting the retina from oxidative stress. With the lipid matrix of the egg yolk being a proven vehicle for the efficient absorption of dietary lutein, it might be possible to increase plasma levels of lutein to therapeutic levels and control or prevent AMD. This, the investigators hope, will be accomplished by means of filtering out harmful blue light and the scavenging of free radicals by lutein and zeaxanthin.

This will be a randomized placebo-controlled trial. The total study time will be two years of which 3 months are actual trial and follow-up time. Every individual will have 3 measuring points at set intervals. At every measuring point (days 1, 45 and 90), these subjects will undergo 6 different non-invasive measuring techniques. These are the mean visual acuity test using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, contrast sensitivity using the Pelli-Robson chart, Scanning Laser Ophthalmoscope (SLO), Optical Coherence Tomography (OCT) and Heterochromatic Flicker Photometry (HFP) and the Reflectometer. A questionnaire will be taken at the beginning of the trail. The invasive part of the study involves blood sampling at all three times, measuring the serum concentration of lutein, zeaxanthin, omega-3 and lipoprotein using the HPLC analysis.

Eligibility Criteria:
Inclusion Criteria:

* No history of ARM or AMD
* 18 years and older
* Non-smoker
* No ocular media opacity
* Uses no nutritional supplements containing Lutein, Zeaxanthin or Omega-3
* BMI \< 30
* No known cardiovascular disease

Exclusion Criteria:

* Diabetes
* Other known eye disease
* Known lipid metabolism disease
* Blood lipid level modifiers (e.g., Statin)
* Known allergy to eggs or egg products
Effects of WiFi Exposure on Sleep

Effects of Wifi exposure on sleep and sleep-related Memory consolidation are investigated in a double-blind, sham-controlled fully counterbalanced study design.

Introduction: Since several years Wireless Local Networks (WLAN, WiFi) are widely spread and operated in households. Many people feel that the presence of radiofrequency technologies impairs their health. Sleep problems are among the most often complained complaints. The present study aims to contribute to answer the question, whether biological effects of a WiFi exposure can be assessed by objective measures. The results of this study will expand the database on possible acute effects of WiFi exposure and thus qualitatively contribute to the discussion whether sleep is affected by exposure from radiofrequency electromagnetic fields.

Methods: A double-blind, sham-controlled experiment in the sleep laboratory with exposure conditions delivered in a balanced randomized cross-over design. Subjective sleep quality of volunteers is assessed by questionnaires. Macro- and microstructure of sleep are measured by polysomnography. Furthermore, a possible impact on sleep related memory consolidation is tested. To do so declarative, procedural and emotional memory tasks are used. Exposure is delivered by a specially developed system, which simulates field strengths and signals occurring in a subject sleeping in the close proximity of a WiFi-access point. This exposure system is necessary to allow for a double-blind implementation and monitoring as well as for the realization of defined exposure parameters.

Eligibility Criteria:
Inclusion Criteria:

* Only right-handed
* non-smokers
* Pittsburgh Sleep Quality Index (PSQI) score \< 5
* no extreme morning/evening preference \[Morningness-Eveningness Questionnaire (MEQ) score ≥ 31 or ≤ 69
* no indication of depression or somatic symptoms as assessed by a medical examination and validated questionnaires \[Patient Health Questionnaires (PHQ-9 and PHQ-15) scores ≤ 5 and ≤ 10, respectively

Exclusion Criteria:

* history of a psychiatric disorder,
* history of a neurological and/or sleep disorder
* excessive daytime sleepiness \[Epworth Sleepiness Scale (ESS) score \> 9;
* non-regular sleep-wake schedule as assessed by a sleep diary
* a regular intake of medication that affects the central nervous system, excessive caffeine and/or alcohol consumption, regular and occasional drug use,
* metal implants
* periodic leg movement arousal index \> 10/h in the Adaptation night
* apnoea-hypopnoea-index \> 5/h in the Adaptation night.
Attitudes Behavior and Practices of Mothering Among an Online Panel

Subjects are users on Amazon's Mechanical Turk (MTurk) platform. MTurk users will be asked to complete a screening survey about family structure. The purpose of the screening survey is to identify MTurk users who are biological mothers of children aged 1.5 to 6 years old, and to collect survey information on how mothers interact with their children, with the aim of better understanding family relationships.

This is a feasibility study that aims to identify a panel of biological mothers of children aged 1.5 to 6 years old from an online pool of participants on Amazon's Mechanical Turk (MTurk; www.mturk.com). MTurk is a novel method to recruit participants from online behavioral studies. Although MTurk workers are anonymous, demographic surveys from previous studies conducted on the web platform indicate that the majority of MTurk users are females living in the U.S. The participant pool may be of scientific interest in pursuing studies that investigate patterns of behaviors and other information pertaining to mothers. A panel of mothers that fit screening criteria may be helpful for future planned studies on attitudes, behavior, and practices surrounding mothering. The MTurk mothers panel will be eligible to participate in future studies involving knowledge, attitudes, and practices of their motherhood and of emotional connection with their children.

Eligibility Criteria:
Inclusion Criteria:

* Biological mothers of children between ages 1.5-6 living in the US

Exclusion Criteria:

* Not having reliable internet access
EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement

This phase II trial investigates the effect of EXPAREL compared to lidocane as a local anesthetic in patients who are undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. This trial aims to see whether EXPAREL or lidocane is able to make patients more comfortable.

PRIMARY OBJECTIVE:

I. To compare Global chest pain score (measured on the Visual Analog Scale \[VAS\] scale) post-procedure and post procedural chest pain (measured on the numerical rating scale), at the time of discharge from recovery between liposomal bupivacaine (EXPAREL) and 1 percent lidocaine.

SECONDARY OBJECTIVES:

I. To compare post procedural chest pain (measured on the numerical rating scale) at the time of discharge from recovery, 24 hours and 48 hours post procedure between EXPAREL and 1 percent lidocaine.

II. To assess the change in global chest pain score (measured on the VAS scale) from baseline to the time of discharge from recovery, and post procedural chest pain (measured on the numerical rating scale) from baseline over time between EXPAREL and 1 percent lidocaine.

III. To compare the number of narcotics within 24 hours, and from 24 to 48 hours post procedure between EXPAREL and 1 percent lidocaine.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive liposomal bupivacaine via injection into the intercostal nerve block.

GROUP B: Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Eligibility Criteria:
Inclusion criteria:

1. Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement
2. Age \> 18

Exclusion criteria:

1. Inability to provide informed consent
2. Study subject has any disease or condition that interferes with safe completion of the study including:

   a. Allergic reaction to EXPAREL
3. Need for pleurodesis
4. Allergies to lidocaine or other local anesthetics.
5. Pregnancy
6. Advanced liver disease where the clinician deems the procedure unsafe