cyrilzakka/clinical-trials huggingface dataset:
Application of Bioimpedance Vector Analysis in Neonates

The goal of this observational study is to learn about the distribution of bioimpedance vector of healthy neonates in China in health conditions. The main question it aims to answer are:whether the distribution of bioimpedance vector of healthy neonates in China is correspond to that in other countries.Participants will be measures by NUTRILAB impedance analyzer (Akern, Florence, Italy).

Data such as demographic data, maternal background, gestational age at birth, gestational history, weight and height, will be collected from medical records.Each day we will measure 3 newborns chosen by simple random sampling, for which we will use Excel function.Bioimpedance analysis will be performed according to the manufacturer's instructions within the first 24 hours of life, using a tetrapolar configuration of electrodes (at 400 μA and 50 kHz) with a NUTRILAB impedance analyzer (Akern, Florence, Italy). BIA data will be acquired when they are still, preferably in quiet sleep, avoiding contact between the upper limbs and trunk, and between the legs. Two outer distal adhesive electrodes will be placed on the dorsal surface of the right hand and foot, proximal to the metacarpal-phalangeal and metatarsal-phalangeal joints, and 2 inner electrodes will be placed proximally on the right fore-arm and pretibial region, leaving 5.5cm of free skin around the outer electrodes. The surface should have no skin lesions and will be cleaned with chlorhexidine solution. R and Xc values will be measured in triplicate in each infant, and the arithmetic mean will be used. The device will be calibrated every 20 evaluations(approximately once a week) using a resistor provided by the manufacturer. All the measurements will be performed at the nursery by the same investigator.We will use BIVA to analyse the result: the components of the impedance vector (R and Xc) will be normalized by the height (R/H \[ohm/m\] and Xc/H \[ohm/m\], respectively). PA is obtained from the arc-tangent ratio Xc:R. To transform it from radians to degrees, the result is multiplied by 180°/π。Using the RXc graph method the bivariate 95% confidence intervals (ellipses) of the mean vectors of the newborns will be established. From the bivariate normal distribution of R/H and Xc/H, the bivariate 95%, 75%, and 50% tolerance intervals will be drawn. We will use the Hotelling T2 test and univariate analysis (F test) by the BIVA software 2002 for the analysis of the CI for the comparison of the subject groups and for the analysis of tolerance intervals. The significance level is set at 0.05 in all tests.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy term neonates of both sexes within 24 hours.
2. Neonates whose parents or guardians consent with the research.

Exclusion Criteria:

1. Infants with some disease and conditions that could interfere in the body composition (such as heart failure, blue light irradiation, sepsis, kidney injury, hepatic failure, transfusion) and newborns with congenital anomalies and/or genetic problems.
2. Neonates whose parents or guardians refuse to participate in the research.
False Positive Results in Newborn Hearing Screening

The purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes.

False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. Getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail NHS with Otoacoustic Emissions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborns

Exclusion Criteria:

* Risk factors for hearing loss
Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.

This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.

The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.

The primary efficacy endpoint is reached six months after device activation.

Eligibility Criteria:
Inclusion Criteria:

* No previous experience with any auditory implant
* 18 years of age or older
* Postlingual onset of severe hearing loss (≥ 4 years of age)
* Limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in Freiburger Monosyllabic word test
* German language proficiency
* Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

* Cochlear malformation or obstruction that would preclude full insertion of electrode array.
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures
* Evidence of central auditory lesion or compromised auditory nerve
* Pregnancy at time of surgery.
Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit

This randomized controlled clinical trial aims to evaluate the effect of nighttime application of eye masks and earplugs on the incidence of delirium and pain levels in pediatric intensive care unit (PICU) patients aged 6-12 years.

Research Questions

This study seeks to answer the following key questions:

Do eye masks and earplugs reduce the incidence of delirium compared to standard nursing care in PICU patients? Do eye masks and earplugs lower pain levels compared to standard nursing care in PICU patients? Study Design

Participants will be randomly assigned to one of the following groups:

Intervention Group: Participants will wear an eye mask and earplugs from 11:00 PM to 07:00 AM for three consecutive nights.

Control Group: Participants will receive standard nursing care without any interventions.

Both groups will be assessed daily at 08:00 AM using the following standardized measures:

Cornell Pediatric Delirium Scale (to assess symptoms of confusion and disorientation) Wong-Baker Faces Pain Scale (to measure pain levels) Glasgow Coma Scale (GCS) (to evaluate consciousness levels) Significance and Impact This study investigates the impact of reducing environmental stimuli (light and noise) on delirium incidence and pain levels in critically ill pediatric patients. The findings may contribute to the development of non-pharmacological interventions aimed at improving patient comfort and care in intensive care settings.

Data Analysis Statistical analyses will be performed using SPSS (version 27) to compare delirium incidence and pain levels between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 6 and 12 years.
* Receiving treatment in the Pediatric Intensive Care Unit (PICU).
* Expected to stay in the intensive care unit for more than 24 hours.
* Having a Glasgow Coma Scale (GCS) score of 9 or above.
* Not receiving sedation.

Exclusion Criteria:

* Children with diagnosed intellectual, auditory, or visual impairments.
* Children with a psychiatric diagnosis.
* Patients using hearing aids.
* Patients diagnosed with brain tumors.
* Patients requiring mechanical ventilation.
* Patients using benzodiazepines or other strong sedative medications.
* Patients with an expected ICU stay of fewer than three days.
Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite (dermis and hypodermis).

EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the EndyMed Pro system.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females age 30 and up
* Subjects with Fitzpatrick 4 to 9 degrees of elastosis
* Subject able to comprehend and give informed consent for participation in this study
* Subject must commit to all treatments and follow-up visits
* Subject must sign the Informed Consent Form

Exclusion Criteria:

* Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
* Subjects with any implantable metal device in the treatment area
* Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months
* Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area)
* Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study
* Subjects who have any form of suspicious lesion on the treatment area
* Subjects with history of keloid formations or hypertrophic scarring
* Pregnant or lactating Subjects
* Subjects with Epilepsy or severe migraines
* Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
* Subjects with any Infection / abscess / pains in treatment target area
* Eczema or dermatitis
* Subjects who suffer from autoimmune disorders or diabetes
* Subjects using blood thinning medications
* Subjects with clotting disorders
* Subjects on drugs or psychologically determined unsuitable for the study
* Subject is suffering extreme general weakness
* Subject objects to the study protocol
* Concurrent participation in any other clinical study
* Physician objection
The Study of Mechanism of Chronic Insomnia Disorder Using Acupuncture Based on Changes of Brain GABA and fMRI

Insomnia disorder is one of the major neuropsychiatric diseases which received more attention in recent years. Disturbances in the amino acid neurotransmitter, gama-amino butyric acid (GABA) and hyperarousal of cortex are hypothesized to contribute to the neurobiology of insomnia. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on insomnia symptom. However, the underlying mechanism remains unclear. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) as well as acupuncture to provide the first in vivo characterization of cortical GABA levels between pro- and post-acupuncture treatment in individuals with chronic insomnia disorder (CID), and use resting state functional magnetic resonance imaging (fMRI) to determine whether CID patients have altered brain connectivity and network parameter changes. The investigators are also exploring the correlation between cortical GABA levels, fMRI parameter changes and abnormalities in sleep parameters and neuropsychology test in CID patients.

Three groups of subjects (CID accepted true acupuncture, CID accepted sham acupuncture and healthy) will participate in the study. All subjects will undergo a laboratory blood test, physical and neurological examination, polysomnography (PSG) and an extensive battery of neuropsychological assessments. All subjects meeting eligibility criteria for the study will complete a baseline MRS and fMRI to evaluate differences in multi-modality brain GABA and fMRI parameters between the patients and healthy. After randomized acupuncture treatment, investigators will compare brain metabolic and functional parameters to elucidate the neural mechanism of acupuncture therapy on insomnia, provide theoretical evidence from the perspective of neurotransmitters and brain network.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic insomnia disorder (CID) met the criteria of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Subject has history of chronic insomnia (difficulty with sleep induction, awakenings during the night, early morning awakening) of at least 3 months
* Must be able to cooperate with cognitive testing and MRI scan

Exclusion Criteria:

* Known pre-existing sleep disorder other than chronic insomnia disorder
* Circadian rhythm sleep disorder determined by sleep-wake cycles of sleep (such as work time at day and night alternation)
* Severe general medical disorders of cardiovascular, endocrine, renal, or hepatic systems
* Clinical diagnosis of AD or Parkinson's neurodegenerative diseases
* Moderate or severe psychological illness
* Clinical history of stroke or other severe cerebrovascular disease
* Clinical history of malignancies disease
* Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
* Alcohol or drug abuse
Study of the Disease Process of Lymphangioleiomyomatosis

Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.

This study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy.

Researchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.

Individuals with pulmonary lymphangioleiomyomatosis develop severe destructive lung disease. Most of them are females of childbearing age. Currently, there is no proven effective therapy and the prognosis is variable. This study is designed to (a) define the clinical course of the disease and (b) elucidate the pathogenesis of the disease at the cellular and molecular levels, in order to develop more effective therapy. To accomplish this, we intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.

Eligibility Criteria:
* INCLUSION CRITERIA:

General admission criteria for patients include one or both of the following:

Findings on lung biopsy diagnostic of LAM;

Findings on chest x-ray and/or chest computed axial tomography consistent with LAM.

Patients with TSC and pulmonary LAM will be included in the study.

Normal non-smokers in the control group are defined as individuals who have not smoked for greater than or equal to 1 year and have no systemic or pulmonary disease.

Normal smokers defined as individuals with no systemic or pulmonary disease, who have smoked for greater than or equal to 1 year and have normal chest x-ray and normal pulmonary function tests may be included if needed as controls for a similar population of patients with LAM.

Pregnant and or nursing women can be included in accordance with Federal Regulations at Subpart B of 45 CFR 46 Subjects who are pregnant and or nursing will be excluded from procedures during their pregnancy that are greater than minimal risk, until they are no longer pregnant and/or nursing. Procedures that will not be completed while the subject is pregnant and/or nursing including: PFTs, Six Minute Walk Test, thoracentesis, bronchoscopy, and measurements with imaging modalities requiring contrast or with radiation exposure such as Chest x-ray, CT scan, MRI, bone densitometry (DEXA). Allowing subjects to be included in the study may glean important information about individuals with uncommon pulmonary disease during and post pregnancy.

EXCLUSION CRITERIA:

Exclusion criteria for patients include:

Age less than 16.

Advanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures.

Exclusion criteria for patients for the formal exercise study and the stress echocardiogram include patients on continuous oxygen. Patients may perform an exercise test that will assess the patient's exercise capacity with activities of daily living.
Netrin-1 and Placenta Accreta

Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation of various cell types. Most of netrin-1 activity occur through signaling pathways induced by its two main receptors, DCC (deleted in colorectal cancer) and UNC5H (uncoordinated-5 homolog). Its receptors have been linked to the processes of apoptosis and angiogenesis. In absence of netrin-1, DCC and UNC5H receptors lead to apoptosis. In contrary, in presence of netrin-1, receptors transduce molecular cascades leading to proliferation, differentiation and migration of the cells. Netrin-1 has been involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and cancer. Serum Netrin-1 levels were high in preeclamptic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-40 years.
* Singleton pregnancy.
* Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping

Exclusion Criteria:

* Multiple pregnancy,
* Fetal anomalies,
* Preterm premature rupture of membranes, or infection
* Any medical disorders, such as thyroid dysfunction, hypertension, and gestational diabetes
* Patients with known bleeding disorders or on anticoagulant therapy.
ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study

The purpose of this study is to evaluate the long-term safety of GT005 in participants with Geographic Atrophy (GA) secondary to AMD who have been treated in an antecedent study.

This is a prospective, multi-centre, long-term, follow-up study for participants who have previously received GT005 in one of the antecedent clinical studies which were prematurely terminated GT005-01 (FOCUS), GT005-02 (EXPLORE) or GT005-03 (HORIZON). Participants from GT005-01 (FOCUS) study with only 1 last study visit to be conducted (Week 240) will remain in the study to complete their last visit. No investigational product will be administered within this study, and participants will be invited to enter ORACLE upon their completion or termination of the antecedent interventional study (whichever is soonest). This study will consist of up to three study visits prior to Week 96, and up to five study visits thereafter, for an overall period of 5-years post-GT005 administration.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to give written informed consent
2. Received GT005 in an antecedent study, GT005-01 (FOCUS, NCT03846193), GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445)
3. Willing to attend study visits and complete the study procedures.
Molecular Diversity of HIV-1 Group O Strains and Treatment Management in Cameroon

Infections with HIV-1 group O are found in 1 to 3 % of persons living with HIV in Cameroon. The natural history and treatment response is not well understood. The natural resistance to non nucleoside reverse transcriptase inhibitors and their possible low sensitivity to protease inhibitors complicate the choice of an adequate treatment options.

This observational study is aimed at evaluating the antiretroviral treatment response of HIV-1 group O infected patients in comparison with HIV-1 group M infected patients. The proposed standardized follow-up will facilitate a better understanding of the natural history and treatment specificities to improve the patients management.

This is a non randomized study, open label, with standardized follow-up. A total of 171 patients


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 group O or group M infection
* No history of antiretroviral treatment (except for PMTCT)
* Criteria for treatment initiation according to the Cameroons national guidelines

Exclusion Criteria:

* Ongoing traditional treatment which could interfere with hepatic function
* Ongoing treatment with rifabutin, rifampicin or rifampin
* Acute hepatitis B infection
* Pregnancy or lactating mother
* HIV-1 group O and group M co-infection
Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* Diabetes patients with Diabetes neuropathy DN4 \> or equal to 4
* Male or female aged from 21 to 65 years
* Informed consent
* HbA1C \< 11%

Exclusion Criteria:

* Prior Hospitalization for Acido- cetosis
* Prior hospitalization for severe hypoglycemia
* Pregnancy
* Hepatitis
* Diabetes foot
* AVB (auriculo-ventricular conduction disturbance)
* Patient treated by antidepressant drugs
* Patient treated with other antiepileptic drug
* Patients with blood ion disturbance
* Patient with neutropenia
* Glaucoma
* Bladder Adenoma
* Alcohol abuse
* Creatinin clearance \< 60 ml/ minute

Other protocol-defined inclusion/exclusion criteria may apply