cyrilzakka/clinical-trials huggingface dataset:
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was designed to target children's specific OTMP deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The current study combines a training intervention (OST) with non-invasive MRI imaging in a pre-/post-design in a randomized two-arm (treatment vs. waitlist) trial to address this question.


Eligibility Criteria:
Inclusion Criteria:

* Age at entry: age ≥ 8.0 and ≤ 11.9 years corresponding to grades 3-5
* Written assent by child and consent by parent or legal guardian
* IQ: Estimated full scale IQ ≥ 85 and language comprehension scores ≥ 8
* Organizational skills deficits defined as elevated (≥ 1SD) pre-treatment Children's Organizational Skills Scales (COSS) Parent Total T-score and at least one COSS Parent Interference item rated as either a 3 or 4 (indicating an above-average level of impairment)
* Must provide adequate MRI data at baseline

Exclusion Criteria:

* Enrolled in a self-contained special education classroom or served by a 1:1 paraprofessional in their classroom
* Absence of signed consent by parent or legal guardian
* Children who dissent regardless of parental permission
* Full scale IQ \< 85
* Children with a recent (past 6 months) or current history of neuroleptic treatment or current treatment with psychotropic medications other than stimulants
* Per history (and medical records if needed) medical illness requiring chronic current treatment
* History of intrathecal chemotherapy or focal cranial irradiation
* Premature birth (\< 32 weeks estimated gestational age or birth weight \< 1500g)
* History of leukomalacia or static encephalopathy, intracerebral hemorrhage beyond grade 2, other specific or focal neurological or metabolic disorder including epilepsy (except for resolved febrile seizures)
* History of traumatic brain injury
* Contraindication for MRI scanning (metal implants, pacemakers, metal foreign bodies or pregnancy)
Mobile Oral Health Intervention Effectiveness on Orthodontic Patients' Oral Hygiene and Oral Health Literacy

Orthodontic patients face unique challenges in maintaining optimal oral hygiene due to the presence of fixed orthodontic appliances, which tend to increase plaque retention, leading to gingival inflammation. Oral Health Literacy (OHL) plays a role in an individual's ability to understand and implement oral hygiene instructions effectively. Mobile oral health interventions involve the use of mobile technology such as smartphones to improve oral hygiene practices and outcomes.

Aim of the study: To assess the effectiveness of a mobile oral health intervention using WhatsApp messages as compared to standard oral hygiene instructions on oral hygiene status and OHL level among orthodontic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing orthodontic treatment with fixed appliances in both arches for the first time.
2. Patients between the age of 16 and 25 years.
3. Participants must own a smartphone with WhatsApp installed.
4. Those who agree to be part of the research project and accept the informed consent.

Exclusion Criteria:

1. The presence of systemic diseases affecting oral health.
2. Patients with cleft lip and/or palate.
3. Functional and orthognathic patients.
4. Previous orthodontic treatment.
5. Patients with a removable appliance.
Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir

The objectives of this data collection activity are to:

1. Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR;
2. Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021;
3. Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR;
4. Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.

Janssen, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the Partnership for Supply Chain Management (PFSCM), the Collaborative Initiative for Pediatric HIV Education and Research (CIPHER) of the International AIDS Society (IAS), and Right to Care have partnered to implement the New Horizons Collaborative to improve and scale-up pediatric HIV/AIDS care and treatment through increased awareness, research, health systems strengthening, and improved access to HIV/AIDS medicines. A primary source of darunavir (DRV) and etravirine (ETR) for pediatric populations in sub-Saharan Africa is through the New Horizons DRV/ETR Donation Program, which was launched in 2014. Under this program, Janssen provides DRV and/or ETR free of charge to eligible national HIV/AIDS programs in sub-Saharan Africa, for use in children and adolescents up to 25 years of age.

Countries currently participating in the New Horizons Collaborative include: Cameroon, Eswatini, Ethiopia, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe. Any country that applies and is approved for receipt of donated product will become eligible for this study when they begin offering donated product to patients.

Prior to the inception of the New Horizons Collaborative, no multi-country data were collected regarding the demographic or clinical characteristics of the target patient population (i.e., children, adolescents, and young people \< 25 years in need of second- or third-line HIV/AIDS treatment). Therefore, the current activity proposes to collect cross-sectional demographic and clinical data at baseline and every six months for patients receiving DRV and/or ETR across participating New Horizons countries. This activity will comprise data abstraction of key demographic, clinical, laboratory and case history indicators and outcomes on each patient who ever received DRV and/or ETR.

Eligibility Criteria:
Inclusion Criteria:

* Ever received darunavir and/or etravirine.
* Under age 25.
* Residing in any of the following countries: Cameroon, Ethiopia, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe.

Exclusion Criteria:

* Above age 25.
* Residing in a country not participating in the New Horizons Collaborative.
Perfusion and Diffusion Mechanism of Intervertebral Disc-Significance With Age, Degeneration, Posture and Stress Loading.

The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image with ADC value measurement, and to determine the relationship between these data and the degeneration of IVDs, the different posture, and different stress-loading status.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of spinal cord injury and degenerative spinal disease
* Normal volunteers

Exclusion Criteria:

- Patients with cancer and infection.
Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China

This real-world observational study aims to reveal the current status of the open-source artificial pancreas system (APS) use among people with T1DM in China and assess the glycemic efficacy and potential related factors of the open-source APS.

This is a real-world observational study analyzing data on open-source artificial pancreas systems(APS) in people with T1DM in China. Data will collected during clinical routine, questionnaires, standard-of-care laboratory tests, and CGM data among whom are willing to share. Baseline data from before the start (up to -3 months) of the open-source APS system and follow-up data at 3, 6, 9, 12, and the following period will be analyzed when available. There are no medical interventions, extra visits, or laboratory tests planned outside the normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed T1DM.
2. Currently use open-source APS for at least 3 months.
3. Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.
4. reside in China.

Exclusion Criteria:

None
A Comparison of Optimal PEEP Determination Guided by EIT and G5 Device in Moderate and Severe ARDS Patients

To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute Respiratory Distress Syndrome Patients by Using:

1. the novel Non-invasive Electrical Impedance Tomography Guided Method
2. the Protective ventilation tool G5(MV)

1. To titrate PEEP guided by EIT. A global inhomogeneity (GI) index and regional compliance based on EIT were developed to quantify the tidal volume distribution within the lung. The aim of this study was to test the feasibility of optimizing PEEP with respect to ventilation homogeneity using the GI index and regional compliance.
2. To titrate PEEP with the Protective Ventilation Tool by G5(MV). The new generation of ventilator will deliver an optimal PEEP on ARDS patients based on their status automatically.

Eligibility Criteria:
Inclusion Criteria:

1. ARDS patients
2. Transferred from FEMH emergency room or Ward into the medical intensive care unit.
3. Patients with invasive mechanical ventilation
4. Patient, agent or consent of families learn about and subjects were willing to sign the consent form.

Exclusion Criteria:

1. burning electric knife used
2. pacemaker used
3. Large area wound is used gauze to cover
4. Wound or burn injuries of the chest wall.
5. Patients included conditions are not met.
The Efficiency of MSC in Refractory Crohn's Disease

The investigators' preliminary study indicates that MSC is effective therapy in treating IBD. But the standard treatment is still lacking and the effect is not stable in IBD patients. This study is to explore the efficacy and standard strategy when using MSC in refractory IBD.


Eligibility Criteria:
Inclusion Criteria:

* Failure or intolerance to GC, immune inhibitors and biological agents treatment
* CDAI between 250-450
* Weight between 40-150 kg
* Normal renal function
* endoscopic or imaging diagnosis of CD in the small intestine, colon ileocolon
* Signed informed consent

Exclusion Criteria:

* HIV or active hepatitis patients;
* Allergic to CT contrast agents, cattle or pig products;
* Stricture or perforation type CD;
* Recieved permanent colostomy;
* Used biological preparation in 3 months
* Used prednisone \> 20 mg/day within 1 month ;
* Patients with short bowel syndrome;
* Need total parenteral nutrition;
* Liver meritorious service is abnormal;
* Suffering from malignant tumor during the last 5 years;
* Combined bacterial or viral enteritis;
* Suffering from intestinal typicality thickening of the living
* Patients with tuberculosis.
A Study to Investigate the Impact of Dose and Dosing Frequency of AZD8848 on the Response on Biomarkers

The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women aged 18 to 55 years (inclusive). Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method, with additional use of a condom by male partners, until 3 months after last dose.
* Female subjects should have a negative pregnancy test at Visit 2 and date of last menstruation consistent of non-pregnancy
* Ability to metabolise AZD8848 (an in vitro screening assay will determine metabolic activity in a blood sample taken at Visit 1 using a pre-defined limit)

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in physical examination
* Structural abnormalities of the nose or nasal disorder symptomatic enough to cause significant nasal obstruction
* Ongoing pregnancy or lactation
* Abnormal immune function
Monitoring Serologic Response to Severe Acute Respiratory Syndrome-2 (SARS-COV-2)/COVID-19 in Children

Individuals susceptible to SARS-CoV-2 and the illness it causes (COVID-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. Pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. Whether children and young adults with inflammatory bowel disease (IBD) or juvenile idiopathic arthritis (JIA) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from COVID-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (MISC), is entirely unclear. This research focuses on the heretofore uncharacterized immune response to SARS-CoV-2 infection in children and young adults with IBD or JIA who are receiving maintenance immunosuppressive biologic therapies. Given the large Connecticut based infusion program, in a region of the United States with a recent large outbreak of COVID-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. The investigators will longitudinally determine antibody development and durability to SARS-CoV-2 in approximately 450-500 children and young adults with IBD or JIA receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. This period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-SARS CoV-2 vaccines. The specific aim is to study the acute and convalescent antibody responses to SARS-CoV-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for IBD and JIA.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 2 to 27 years inclusive
2. Patients receiving biologic infusions for inflammatory or rheumatologic disorders at the Connecticut Children's Infusion Center, at a minimum frequency of 2 infusions over a 4 month period
3. Consent/assent as indicated
4. Have vein access placement as standard of care

Exclusion Criteria:

1. Patient and/or parent/legal guardian refused participation
2. Inability to draw requisite blood sample for serum collection
Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy

This study is designed to evaluate the efficacy and safety of hydrocodone in patient-controlled intravenous analgesia (PCIA) during gynecological laparoscopy, thus to explore suitable PCIA scheme to optimize postoperative pain management for patients undergoing gynecological laparoscopic surgeries.

The controlled group will receive sulfentanil for PCIA, and the test group will receive hydrocodone for PCIA. NRS scores at 1, 6, 24 and 48 hours post-surgery will be recorded. The usage of rescue analgesics and adverse events will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* selective laparoscopic hysterectomy
* general anesthesia
* ASA classification I - III
* aged 18 - 65 years

Exclusion Criteria:

* allergy to oxycodone or any other drugs will be used in the study
* preoperative opioids medication
* opioids abuse
* hepatic or renal dysfunction
* cardiovascular or pulmonary dysfunction
* lack of full civil capacity or refuse to participate
Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. The objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium

Eligibility Criteria:
Inclusion Criteria:

1. Hospital admission ≤30 hours at noon on enrollment day
2. Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
3. Age ≥50 years

Exclusion Criteria:

1. At significant risk for pre-existing circadian abnormalities:

   * Severe chronic brain injury (Injury greater than 30 days ago resulting in the inability to live independently)
   * Acute brain injury of any severity (Injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor)
   * Documented circadian disorder or blind/disease of the optic nerve
   * Current history of substance abuse including alcohol (use in last 30 days)

3. Transferred from an outside hospital. 4. History of bipolar disease 5. Paralyzed (due to injury, disease or medications)

Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).
Multi-site Anesthesia Randomized Controlled STudy of End Tidal Control Compared to Conventional Anesthesia Results

This is a clinical, single blind, randomized, prospective research study. The purpose of this pivotal study is to collect and analyze data on the investigational End tidal Control (Et Control) option feature. To demonstrate that End tidal Control (Et Control) performance is non-inferior to conventional anesthesia practice in an adult surgery population by comparing the performance of the Et Control Arm (investigational arm) to the Control Arm (fresh gas mode).

The purpose of this pivotal study is to demonstrate that End tidal Control performance is non-inferior to conventional anesthesia practice in an adult surgery population, and support a marketing application in the U.S. for clearance of this feature.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years old or greater.
2. Scheduled to undergo general inhaled anesthesia that can be safely exposed to 100% oxygen for up to 2 minutes during general anesthesia.
3. Expected to have airway secured with laryngeal mask airway (LMA) or endotracheal tube.
4. Undergoing a surgical procedure that is anticipated by the investigator to take greater than or equal to 1 hour (operative time measured from induction to cessation of general inhalation anesthetic).
5. American Society of Anesthesiologists (ASA) status classification system I through III:

   1. ASA Physical Status 1 = a normal healthy patient
   2. ASA Physical Status 2 = a patient with mild systemic disease
   3. ASA Physical Status 3 = a patient with severe systemic disease
6. Undergoing intravenous induction.
7. Ability to provide written informed consent.

Exclusion Criteria:

1. Have emergency medical condition requiring surgery.
2. Are female subjects, who are pregnant or lactating.
3. Any subject undergoing cardiac bypass surgery.
4. Any subject undergoing open chest surgery.
Study on the Level of Neuromuscular Blockade

On the basis of moderate pneumoperitoneum pressure(10 mmHg), this study evaluates the effect of different level of neuromuscular blockade to gastrointestinal barrier function during laparoscopic gastrectomy. 83 patients are randomized to 2 arms ,The patients in deep neuromuscular blockade group（group D, PTC=1-2）will receive high dose rocuronium (0.5-0.6 mg/kg/h) ;While the patients in moderate neuromuscular blockade group（group M, TOF=1-2）will receive moderate dose rocuronium (0.2-0.3 mg/kg/h)


Eligibility Criteria:
Inclusion Criteria:

1. Age:40-80;
2. BMI \< 30kg/m2；
3. ASA classification:Ⅰ-Ⅲ；
4. Undergoing elective laparoscopic gastrectomy.

Exclusion Criteria:

1. Preoperative history of inflammatory intestinal diseases, intestinal flora disorders, obstructive jaundice, intestinal obstruction, irritable bowel syndrome and other digestive diseases;
2. Severe heart, lung, liver, kidney, brain and other diseases;
3. Serious infection, pancreatitis, burns, trauma, need a large dose, long-term use of antibiotics before the operation;
4. A history of abdominal surgery;
5. Combined with gravis myasthenia, serious electrolyte disorders or neuromuscular diseases.
Polyunsaturated Fatty Acids in Child Nutrition

Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development.

Subjects are randomly assigned to one of three groups:

* Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3 LC-PUFA metabolism)
* Fatty fish (preformed n-3 LC-PUFA, especially DHA)
* Corn oil (as control group, high in n-6 PUFA, common in complementary food).

The intervention starts with the beginning of complementary feeding as generally recommended between 4 to 6 months of age and ends at the age of 10 months. For this period of time subjects of all groups receive commercial vegetable-potato-meat-meals as part of complementary food which only differs in the fatty acid composition.

A well balanced supply of polyunsaturated fatty acids, in particular the omega-3 long chain docosahexaenoic acid (DHA), in early childhood is essential for children's cognitive and visual development. DHA can either be supplied preformed in the diet (e.g. via fatty fish) or synthesised by conversion of its essential precursor alpha-linolenic acid (e.g. via rapeseed oil). The study examines the effect of two different approaches to optimise infants´ fatty acid status.

The study sample consists of healthy newborns and their mothers (3 x 57 infants according to a priori power calculation) who are enrolled in delivery hospitals in the region of Dortmund, Germany. In total, the individual study program covers the first 10 months of infant's life. Biomarkers of fatty acid status from the mother are collected 8 weeks pp for the estimation of pre- and perinatal fatty acid supply. Additionally, information on maternal diet during pregnancy and after delivery is assessed. The intervention covers the period of complementary feeding (from 4 to 6 months of age until 10 months of age). In all groups the specific study food is given 5 to 7 times a week, whereas 2 of these are fish meals in the fatty fish group. At the age of 4 and 10 months blood samples are collected from the infants to examine the effect on blood fatty acid status. Parameters of visual and cognitive development are also assessed at the age of 4 and 10 months using VEP examinations and Bayley scales. Infants´ dietary intake is assessed from the end of the 2 months until 10 months of age using continuous weighed dietary records.

Eligibility Criteria:
Inclusion Criteria:

* a term healthy newborn infant ( birth weight \> 2500 g, gestational age \> 37 weeks
* German speaking mother
* the intention of the mother to breast-feed the children and to feed study menus at least 5 times per week beginning in the fifth to seventh month of life.

Exclusion Criteria:

* preterm children
* twins