cyrilzakka/clinical-trials huggingface dataset:
Brain Activity by Magnetoencephalography for Children

Investigate the differences in activation of brain networks during performing functional tasks for children with attention deficit hyperactivity disorder with developmental delays and typical development

A total of 12 children with attention deficit hyperactivity disorder with developmental delays and12 children with typical development will be enrolled.

The following evaluations will be evaluated by the investigator who is blinded to the group's classification.

Working task-related functions, such as Beery-Buktenica Visual-Motor Integration, Sensory Profile, the Chinese version of Swanson, Nolan and Pelham version IV, and Chinese version of Wechsler Intelligence Scale for Children-IV)

Non-working memory-related functions, such as Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form (CHQ-PF 28), Pediatric Quality of Life Inventory (PedsQL), and physical function (10 meters normal and fast walking, stair ascent, stair descent, and 5 times chair rising and timed up and go test)

All participants will be investigated by magnetoencephalography and eye-tracking system to identify the difference of brain network activation during resting and performing tasks and between-group differences.

Brain magnetic resonance image study will be performed for matching of brain localization.

Eligibility Criteria:
Inclusion Criteria:

* children with attention deficit hyperactivity disorder with development delays
* intelligence quotient 70 or greater

Exclusion Criteria:

* age less than 4 or greater than 10 of children
* intelligence quotient less than 70
Effects of Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Low Back Pain

This study is a Randomized Control Trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. Group A will be receiving myofascial release using stripping technique whereas, Group B will be receiving Instrument Assisted Soft Tissue Mobilization using long bar tool. Afterwards, post-treatment stretching would be performed in both the groups. Final assessment of pain, range of motion and disability will be done on last treatment session.

Low Back Pain is a major cause of disability worldwide, affecting both genders equally at some point in their lives. 95% of low back pain is mechanical in origin which is the pain originating from spine, intervertebral discs and surrounding soft tissue structures. A total of 50 participants will be divided into two groups by coin toss method, based on the eligibility criteria. Baseline assessment of pain using NPRS, range of motion using Gravity-Based Inclinometer and disability using Oswestry Disability Index will be done on 1st session for both the groups. Group A will be receiving moist heat for 10 minutes followed by myofascial release and post-treatment stretching. Whereas, on the other hand, Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using Graston G6 long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees over lumbar area followed by post-treatment stretching. Total treatment plan will be of 3 weeks, consisting of total 9 sessions, 3 sessions on alternate days. Final assessment will be done for pain, range of motion and disability on last session at 3rd week. Gentle icing would be recommended in case of itching and bruising over the treated area.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-50 years with diagnosed chronic mechanical low back pain.
* Males and females both.
* Participants having symptoms of duration more than 3 months.
* Numeric Pain Rating Scale (NPRS) score of 5 or more.

Exclusion Criteria:

* Patient with a history of recent spinal surgery and related trauma.
* Participants with a history of pregnancy.
* Participants with a history of infection, tumor and spinal fracture.
* Participants with diagnosed Psychiatric Disorder.
INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)

The purpose of this study is to assess the efficacy and safety of INCMGA00012 in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III non-small cell lung cancer (NSCLC). The study will randomize approximately 360 participants in a 2:1 ratio into the INCMGA00012 in combination with CRT followed by consolidation therapy with INCMGA00012 treatment group and placebo in combination with CRT followed by consolidation therapy with placebo treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC that is locally advanced and unresectable.
* Adequate tumor sample from fresh biopsy or archival tissue block must be available.
* Evaluable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group performance status 0 to 1.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Receipt of cancer treatment for this malignancy, including but not limited to radiation therapy, investigational agents, chemotherapy, and immunotherapy for disease under consideration.
* Recent major surgery within 4 weeks before entry into the study.
* Any medical contraindication to platinum-based doublet chemotherapy.
* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic consolidation doses of corticosteroids (\> 10 mg/day of prednisone or equivalent).
* Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Mixed small cell and NSCLC histology.
* Evidence of interstitial lung disease or active noninfectious pneumonitis.
* Participants who are HIV-positive.
* History of organ transplant, including allogeneic stem cell transplantation.
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool

HYPOTHESIS:

During anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in patients \< 6 years old, where FRC and pulmonary closing volume may overlap. New borns and children \<1 year old are especially vulnerable.

OBJECTIVES:

1. Validate "air test" as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics.
2. Determine what other factors contribute to atelectasis development in pediatrics

METHODS:

30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks and16 years old.

Baseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after intubation during a 5 min long "air test" trial (FiO2 0.25). lung collapse will be verified by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted upon lung US verification by a blind researcher.


Eligibility Criteria:
Inclusion Criteria:

* General anesthesia
* Perioperative risk classification (ASA) I, II, III
* Newborns (postconceptional age\> 45 weeks) to 16 years
* Need for oral / nasotracheal intubation

Exclusion Criteria:

* ASA \> III
* Basal SpO2 \< 97% on air in supine position
* Preoperative need for oxygen therapy and / or high-flow nasal cannulas
* Expected Difficult airway
* Presence of craniofacial disorders that may compromise ventilation
* Hemodynamic instability and / or need for inotropics
* History of untreated heart disease
* Presence or history of pneumothorax
* Presence of untreated congenital pulmonary disorders
* Refusal to participate in the study
Effect of Cervical Multifidus Muscle Area on Interlaminar Epidural Steroid Injection Outcomes

Cervical radiculopathy is one of the most important causes of chronic neck pain. Cervical epidural steroid injections including interlaminar approach are frequently used for treatment option in patients that more conservative modalities are ineffective.

Paraspinal muscles have an important role in supporting neck movements and providing stability of the cervical spine. The multifidus muscle, located in the deepest part of the neck extensor muscle group, has become the muscle that is frequently emphasized in spinal pain in recent years. In the literature, it has been shown that the multifidus muscle on the affected side is atrophied in patients with cervical radiculopathy.

Although many factors are known to be effective on the outcomes of cervical interlaminar epidural injection, there are limited data on the effect of the multifidus muscle area. In this retrospective study, it was planned to investigate the effect of the multifidus muscle area on the results of cervical interlaminar epidural steroid injection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral radicular pain due to cervical disc herniation for at least 3 months
* Patients with disc herniation level C5-C6
* Patients who are unresponsive to other conservative treatments and who have undergone cervical interlaminar epidural steroid injection

Exclusion Criteria:

* Patients with incomplete medical records (absence of MR imaging, incomplete data of 3rd week and 3rd month follow-up periods after cervical interlaminar epidural steroid injection)
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole

The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.

Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* closed globe injury
* identification of full-thickness macular hole by optical coherence tomography within one month after trauma

Exclusion Criteria:

* open globe injury
* coexistence of idiopathic macular hole
* severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)
* combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)
* coexistence of high myopia
* coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola
* coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)
Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants less than 32 weeks gestation

Exclusion Criteria:

* infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.
Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

The study will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels, respectively. The intravenous infusion will be initiated by a pre-defined bolus dose infusion.

Primary objective

To assess the dose-response relationship of tafoxiparin on the labor time defined as the time from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due to Primary Slow Progress of Labor including prolonged latent phase and Labor Arrest.

Secondary objectives

To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy parameters evaluated in the protocol. PK (pharmacokinetic) response in pregnant women during labor.

Methodology

All term-pregnant, nulliparous women presenting to the delivery ward are potential study patients unless they have already been enrolled in another clinical study. Subjects may be pre-informed about the study through the use of advertisements or information at the physician/midwife visits during pregnancy and at hospital admission.

The whole study includes the following steps:

* Screening and Baseline including informed consent and randomization
* Labor
* Discharge
* Follow-up at 8 (+/-1)weeks - End of study
* Safety follow up of infant at 6 months, +/-4 weeks, by telephone interview

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women of ≥18 to ≤45 years of age
2. Nulliparous
3. Gestational age \> 36 weeks + 6 days confirmed by ultrasound
4. Experience slow progress of labor including prolonged latent phase and labor arrest (according to the respective definitions) etc

Exclusion Criteria:

1. Subjects with secondary slow progress or secondary labor arrest
2. BMI≥35 during first trimester of pregnancy
3. Breech presentation or other abnormal presentations etc
Effects of Consuming Red Meat on the Gut Microbiota in Young Adults

The purpose of this study is to assess the impact of consuming unprocessed and processed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial.

The purpose of this study is to assess the impact of consuming processed and unprocessed red meat on gut microbiota in young healthy adults in a cross-over, randomized controlled feeding trial. The hypothesis is that compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (1) consuming the LOV diet with unprocessed red meat or processed red meat (omnivorous diet) will shift the gut microbiota with greater abundance of the bacteria Lactobacillus and other SCFA producers such as Clostridium XIVa, and no increase of pathogenic bacteria. The concentration of SCFA in stools will also increase in subjects consuming the unprocessed red meat diet. Compared to consuming a meat-free lacto-ovo vegetarian (LOV) diet, (2) consuming the LOV diet with processed beef and pork (omnivorous diet) will result in a comparable shift in gut microbiota as unprocessed red meat, except for greater abundance of taxa Erysipelotrichaceae and lower abundance of Lachnospiraceae.

Eligibility Criteria:
Inclusion Criteria:

* male or female,
* 20-35 years old,
* BMI 20.0-29.9 kg/m2,
* fasting serum total cholesterol \<240 mg/dL, low-density lipoprotein cholesterol \<160 mg/dL, triglycerides \<400 mg/dL, and glucose \<110 mg/dL;
* systolic/diastolic blood pressure \<140/90 mmHg;
* body weight stable for 3 months prior (±3 kg); stable physical activity regimen 3 months prior;
* medication use stable for 6 months prior and not using medications or supplements known to impact gut function;
* on-smoking; not drinking more than 2 alcoholic drinks per day;
* non-diabetic,
* no history of gastrointestinal disorders, surgeries or cancers;
* non-pregnant and not lactating.
* Participants must be willing and able to consume the prescribed diets (lacto-ovo vegetarian and omnivorous).

Exclusion Criteria:

* male or female \< 20-\>35 years old,
* BMI \<20.0- \>29.9 kg/m2,
* fasting serum total cholesterol \>240 mg/dL, low-density lipoprotein cholesterol \>160 mg/dL, triglycerides \>400 mg/dL, and glucose \>110 mg/dL;
* systolic/diastolic blood pressure \>140/90 mmHg;
* body weight stable for \<3 months prior (±3 kg);
* stable physical activity regimen \< 3 months prior;
* medication use unstable for 6 months prior and using medications or supplements known to impact gut function;
* smoking;
* drinking more than 2 alcoholic drinks per day;
* diabetic,
* history of gastrointestinal disorders, GI surgeries or GI cancers;
* pregnant or lactating.
Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study

The goal of this randomized controlled trial is to compare the effect of receiving 6 months of monetary support for healthy food through a food delivery platform on change in glycosylated hemoglobin (HbA1c) levels among adults with type 2 diabetes mellitus with glycemic control that is above target level.

The main study aims are to:

1. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces glycosylated hemoglobin levels within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.
2. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces medical resource utilization within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.

Eligible Kaiser Permanente adult members will be randomized to one of two groups:

1. Intervention arm, in which subjects will receive 6 months of monetary support (with up to 4 free home deliveries and no service fees) through the Instacart platform to select and receive healthy foods (e.g., vegetables and fruit).
2. Control arm, in which subjects will receive 6 months of free home deliveries and no service fees for up to 4 deliveries each month through the Instacart platform.

Glycosylated hemoglobin level will be assessed at baseline and at 6 months after enrollment. Medical resource utilization will be evaluated at 3 months, 6 months, and 12 months after enrollment. Patient-reported outcomes (i.e., diabetes quality of life, nutrition security, dietary habits, social needs, and food security) will also be assessed at baseline, 6 months, and 12 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years old at enrollment
* Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance
* Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus)
* At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months
* Current access to the internet via computer or mobile device
* No interpreter needed

Exclusion Criteria:

* Advanced or end-stage kidney disease (estimated glomerular filtration rate ≤15 ml/min/1.73m\^2 or receiving outpatient dialysis or having a prior kidney transplant)
* Known pregnancy at time of identification
Type 1 Diabetes and the Brain in Children

The investigators have previously studied a group of young children with T1D using brain MRI, age-appropriate neurocognitive testing and continuous glucose monitoring, followed for 18 months. The investigators observed significant differences in gray matter volumes and white matter microstructure in the children with diabetes as compared to controls. These differences appeared to increase over time, with slower rates of brain growth in the T1D group (Mazelli, et al, Diabetes 2014; Barnea-Goraly, et al, Diabetes Care 2014; Mauras, et al, Diabetes 2015). In this new protocol the investigators will include the same children with T1D and healthy controls previously studied and recruit new similar subjects to replace those lost by attrition. The investigators will be using structural and functional brain MRI, neurocognitive testing and measures of glycemic control, to determine if changes in the brain persist or worsen over longitudinal follow up, and whether these changes are associated with measures of glycemic control and neurocognitive metrics as these children grow and progress through puberty.

Study participation will last about 2 to 2 1/12 years and will include a brain MRI without sedation, as well as a functional MRI and neurocognitive testing. The children with T1D will wear a continuous glucose monitor (CGM), will follow up every 3 months and will be asked to wear the CGM each time. The structural and functional MRI and neurocognitive testing will be repeated 2 yrs from baseline.

The healthy controls will also undergo MRI and cognitive testing as well as have a blood sample at baseline and after 2 years.

Parents of newly recruited subjects will also have abbreviated IQ testing.

Eligibility Criteria:
Inclusion Criteria for T1 Diabetes Group:

* Diabetes diagnosed after age 6 months
* Gestational age \>34 weeks, birth weight \>2kg

Inclusion Criteria for Healthy Control Group:

* Normal HbA1C and fasting blood glucose
* Negative diabetes auto-antibodies (those that are siblings of T1D patients)
* Gestational age \>34 weeks, birth weight \>2kg

Exclusion Criteria for Both Groups:

* History of mental retardation, language or learning disability
* Known genetic or medical problem that could impair brain development
* Abnormality of the brain/nervous system, visual or hearing problem
* History of seizures not associated with fever
* Previous inpatient psychiatric treatment
* Unable to have a MRI of the head due to metal appliances
Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™

The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children \<=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.


Eligibility Criteria:
Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

* Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
* Hospitalised at one of the participating centres in Belgium;
* A stool sample has been provided for a rotavirus detection test during the study period;
* Laboratory test result of rotavirus is available.

Exclusion Criteria:

• None.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for SCI

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Spinal Cord Injury.

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Spinal Cord Injury (SCI). This patient funded trial aims to study the safety and efficacy of intravenous and intrathecal delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of SCI. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Spinal Cord Injury
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
* Anticoagulation medicine use