linjc16/ctgov huggingface dataset:
Child and Adolescent Registry for Participants With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed. The study has 16 active clinical sites and a virtual site that widens participation to anywhere in the United States. For more information about the study or to access the Online Patient Enrollment System, visit the CATNAP website: https://catnap.healthie.net/welcome or email catnap@pulseinfoframe.com. The Online Patient Enrollment System, CATNAP website, can also be found in the references section.

Official Title
-----------------
Children, Adolescents and Their Providers: the Narcolepsy Assessment Partnership (CATNAPTM)

Conditions
-----------------
Narcolepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child or adolescent with a physician-confirmed diagnosis of narcolepsy Age less than 18 years Willing to participate in the Registry and complete the informed consent form Able to participate in English based registry Exclusion Criteria: Age 18 years or more Fail to complete the informed consent form

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve Understanding of Natural History of Pediatric Narcolepsy |  | Up to 4 years | 
| Characterize the Presentation, Identification, and Diagnosis of Narcolepsy in Pediatric Participants |  | Up to 4 years | 
| Understand Treatment Practices and Outcomes Captured by Treatment Regimen and Rational for Changes |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in Quality of Life (QoL) as Measured by Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Questionnaire |  | Up to 4 years | 
| QoL - Pediatric Quality of Life Inventory (PedsQL) |  | Up to 4 years | 
| Change in frequency of child ehavioral problems utilizing the Child Behavior Checklist (CBCL) |  | Up to 4 years | 
| Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationship-Parent Proxy Short Form v2.0 |  | Up to 4 years | 
| Caregiver Work Limitations Questionnaire (C-WLQ) |  | Up to 4 years | 
| Work Productivity and Activity Impairment (WPAI) |  | Up to 4 years | 
| Change in Caregiver Well-being Measured by the Caregiver Well-Being Scale (Shortened) |  | Up to 4 years | 
| Change in Level of Social Support using the Social Support Survey Instrument |  | Up to 4 years | 
| Change in Pittsburgh Sleep Quality index (PSQI) scores |  | Up to 4 years |
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy

Study Overview
=================
Brief Summary
-----------------
Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.

Official Title
-----------------
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy But Without Optic Disc Pit Nor High Myopia

Conditions
-----------------
Macular Retinoschisis, Macular Detachment, Normal Tension Glaucoma

Intervention / Treatment
-----------------
* Procedure: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with macular retinoschisis and detachment associated with normal tension glaucoma Exclusion Criteria: Optic pit maculopathy, high myopia

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Macular retinoschisis and detachment<br> | Procedure: Optical coherence tomography<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography | Anatomical improvement detected with optical coherence tomography after surgical intervention. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual recovery | The number of the patients with visual recovery after surgical intervention | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular retinoschisis, Macular detachment, vitrectomy
Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk

Study Overview
=================
Brief Summary
-----------------
Investigation of the cerebrospinal fluid proteom in preterm infants with posthemorrhagic hydrocephalus in our neonatology center with analysis for modulation of proteom in dependence of breastmilk feeding and way of application such as via gavage tube, oral or nasal application.

Detailed Description
-----------------
Since the nasal route might be highly effective for neurotrophins and other growth factors the cerebrospinal fluid will be investigated using mass spectrometry to identify modulating effects of intranasal breast milk application on the cerebrospinal fluid proteom.

Official Title
-----------------
Proteomics of Cerebrospinal Fluid of Preterm Infants With Posthemorrhagic Hydrocephalus With Focus on Intranasal Breast Milk.

Conditions
-----------------
Hydrocephalus in Infants

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infant with hydrocephalus and regular drainage Exclusion Criteria: Inborn error of metabolism

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention, only observational.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrospinal fluid proteom | Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application | weeks |
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI >27 kg/m2.

Official Title
-----------------
Treating Overweight Youth: A Family Based Approach in Primary Care

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Behavioral: family based lifestyle and behavioral counseling
* Behavioral: counseling focused on the child


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2-5 year old with a BMI greater than the 85th% for age and sex one overweight parent (BMI>27kg/m2) child with normal developmental milestones history of adherence to 90% of scheduled primary care visits parent must be at 5th grade reading and speaking of English language or the spanish language no plans on moving out of the area for the 2 years subsequent to enrollment Exclusion Criteria: child with a height 2 SD below the mean for age and sex and/or pathological growth velocity SGA any chronic disorders influencing energy intake and/or growth any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program any medication known to have the potential of affecting weight changes parent or child with psychiatric and/or eating disorder participating mother who is pregnant or planning a pregnancy parent being acquainted with the parent of a previously randomized study participant

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention- Lifestyle family based<br>Behavioral family based | Behavioral: family based lifestyle and behavioral counseling<br>* 16 group meetings<br>|
| Active Comparator: Information control<br>Child intervention only | Behavioral: counseling focused on the child<br>* 16 meetings<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent BMI overweight for child and parent |  | baseline-6,12,18, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity |  | baseline, 6,12,18,24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMI >85%for age and gender
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis

Study Overview
=================
Brief Summary
-----------------
This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).

Official Title
-----------------
Human Factors Study for the Evaluation of the Methotrexate Prefilled Pen (50 mg/mL) for Subcutaneous Injection in Pediatric and Adolescent Patients With Juvenile Idiopathic Arthritis

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Device: methotrexate prefilled pen


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: patient of either gender aged ≥2 to <21 years of age is a suitable candidate for treatment with injectable methotrexate for JIA per the patient's primary rheumatologist, with the previous or current diagnosis of active polyarticular course JIA Main Exclusion Criteria: Is a female patient who is pregnant, trying to become pregnant, or breastfeeding, or of childbearing potential, sexually active but not practicing a highly reliable method of birth control during the study and at least 6 months thereafter Has contraindications for methotrexate Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than JIA Is unable, or does not have a caregiver able to comprehend written labeling and training materials

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methotrexate<br> | Device: methotrexate prefilled pen<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of test case scenarios with observation and performance measures | Test case scenarios were designed to determine if the potential risks associated with the use of the prefilled pen were mitigated by information contained in the patient leaflet and the training provided to each patient or caregiver. The test case scenarios with observation and performance measures will be evaluated. | 8 days |
Impact of the CT Scan in Patients With Suspected Covid-19

Study Overview
=================
Brief Summary
-----------------
The diagnostic performance of the scanner in the indication of suspected Covid-19 is not yet well known, especially in comparison with the results of RT-PCR. The potential use of the scanner as a tool for quantifying the severity of Covid-19 disease is not yet well established, especially the variations between readers or between measurement techniques. The impact of the scanner in predicting the fate of patients with confirmed Covid-19 is not yet known.

Official Title
-----------------
Diagnostic Performance and Predictive Impact of the CT Scan in Patients With Suspected Covid-19

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Adult patient (≥18 years old) Patient admitted to Strasbourg University Hospitals for suspicion of Covid-19, between 03/01/2020 and 04/29/2020 Availability of at least one chest CT scan during hospitalization Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Non-inclusion criteria Patient who expressed his opposition to participating in the study Patient under legal protection Patient under guardianship or guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of the chest scanner in suspected Covid-19 |  | Files analysed retrospectively from March 01, 2020 to April 29, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Chest scanner, CT scan, RT-PCR
Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.

Official Title
-----------------
A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma

Conditions
-----------------
Refractory Glaucoma

Intervention / Treatment
-----------------
* Device: XEN Glaucoma Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy Exclusion Criteria: Angle closure glaucoma where angle has not been surgically opened Previous glaucoma shunt/valve in the target quadrant Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis) Active iris neovascularization or neovascularization of the iris within six months of the surgical date Anterior chamber intraocular lens Presence of intraocular silicone oil Vitreous present in the anterior chamber

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XEN Glaucoma Stent<br> | Device: XEN Glaucoma Stent<br>* Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline |  | Baseline to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean decrease in IOP |  | Baseline to Month 12 |
THE EFFICIENCY OF FASCIAL PLANE BLOCKS IN BARIATRIC SURGERY

Study Overview
=================
Brief Summary
-----------------
Bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. Although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery [1]. Opioids remain the first choice for multimodal analgesia in the treatment of postoperative pain. Providing analgesia after bariatric surgery might be challenging due to a high prevalence of obstructive sleep apnea syndrome and the increased sensitivity to respiratory depression triggered by opioid overuse after surgeryThe most common plane block techniques utilized during laparoscopic bariatric surgery are transversus abdominis plane block (TAP), rectus sheath block (RB), the erector spinae plane block (ESPB) and the external oblique intercostal block (EOI). In this study, we have evaluated the auxiliary benefit of these various techniques in reduction of the postoperative in bariatric surgery. patients who had laparoscopic bariatric surgery at VKV American Hospital between January 2019 and December 2021 were reviewed retrospectively.

Official Title
-----------------
CAN POSTOPERATIVE PAIN BE PREVENTED IN BARIATRIC SURGERY? EFFICACY AND USABILITY OF FASCIAL PLANE BLOCKS: A RETROSPECTIVE CLINICAL STUDY

Conditions
-----------------
Regional Anesthesia Morbidity, Post Operative Pain, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective bariatric surgery Exclusion Criteria: Patients with a history of cerebrovascular events Alzheimer's and dementia inadequate cognitive functions history of chronic pain long-term opioid therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAP + RB<br>transversus abdominis plane block and rectus sheath block | Procedure: Bariatric surgery<br>* Patients undergoing elective bariatric surgery<br>|
| ESPB<br>Erector spinae plane block | Procedure: Bariatric surgery<br>* Patients undergoing elective bariatric surgery<br>|
| EOI<br>External oblique intercostal block | Procedure: Bariatric surgery<br>* Patients undergoing elective bariatric surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative analgesia | Postoperative pain assessment of patients will be made with a numeric rating scale (NRS). Postoperative opioid consumption will be examined | 0 - 24 hours |
Short Time Low PEEP Challenge and Mini Fluid Challenge

Study Overview
=================
Brief Summary
-----------------
Optimizing fluid therapy is one of the main concerns for anesthesiologists during the intraoperative period. It becomes even more important in high-risk long lasting surgeries as pancreaticoduodenectomy. Therefore evaluating fluid responsiveness prior to fluid loading is highly recommended. To the best of our knowledge there is no study comparing the abilities short time low PEEP challenge and mini fluid challenge in predicting fluid responsiveness.

Official Title
-----------------
Ability of Short Time Low PEEP Challenge and Mini Fluid Challenge to Predict Fluid Responsiveness During Pancreaticoduodenectomy

Conditions
-----------------
Intraoperative Care, Fluid Responsiveness

Intervention / Treatment
-----------------
* Other: Fluid Loading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing pancreaticoduodenectomy Exclusion Criteria: Body mass index (BMI) > 35 kg / m2 any ventricular dysfunction Crs < 35 ml / cmH2O valvular heart disease ASA score > 3 cardiac arrhythmia history of lung disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Undergoing Pancreaticoduodenectomy<br> | Other: Fluid Loading<br>* Hemodynamic and ventilatory parameters will be recorded at five time points (T1 - T5). After baseline meausrements (T1), additional 5 cmH2O PEEP will be applied to patients for 30 seconds (short time low peep challenge, SLPC). Prior to PEEP lowering T2 measurement will be performed. T3 measurement will be performed one minute after PEEP is decreased to its initial value and will be recorded as the second baseline. Thereafter, 100 ml isotonic saline will be infused over one minute (MFC). T4 measurement will be performed one minute after MFC is completed,. Lastly, T5 measurement will be performed three minutes after additional 400 ml of isotonic saline is infused within 10 minutes to complete 500 ml of fluid loading.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the abilities of two methods to predict fluid responsiveness defined as an increase in stroke volume index >15% after fluid loading | Difference between the area under reciever operating characterisitcs curve of two methods | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraoperative monitoring, fluid therapy