linjc16/ctgov huggingface dataset:
Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric

Study Overview
=================
Brief Summary
-----------------
Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population. The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score.

Official Title
-----------------
Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric

Conditions
-----------------
Surgical Intervention, Minor

Intervention / Treatment
-----------------
* Other: Questionnaire Quality-of-recovery 15 (QoR-15)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient underage over 7 years and up to 17 years and 9 months Programming surgery as part of routine management Patient affiliated with a health insurance social Parental authority holders and the patient agreeing to participate in the study Exclusion Criteria: Patients with severe sensory impairment in preoperation preventing reliable participation in the questionnaire Patients at risk of severe cognitive or sensory impairment in postoperative Patients with language difficulties in the language of administration of the questionnaire Patients who can not express their non-opposition to participation in the study Refusal of holders of parental authority and/or refusal of the patient to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire Quality-of-recovery 15 (QoR-15)|Children will use the questionnaire Quality-of-recovery 15 (QoR-15)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Quality-of-recovery 15 score | functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
questionnaire Quality-of-recovery 15 (QoR-15)
Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways

Detailed Description
-----------------
Main objective: (1) To investigate the expression of mucins and antimicrobial peptides in patients with severe COPD and their relationship with the presence of bacteria in the airway

Official Title
-----------------
Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Bacterial Infection in COPD

Intervention / Treatment
-----------------
* Procedure: Bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Exclusion Criteria: Acute exacerbation in the last 4 weeks

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bronchoscopy<br>Procedure | Procedure: Bronchoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucins in sputum |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial peptides in sputum |  | Day 1 |
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%. Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.

Official Title
-----------------
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

Conditions
-----------------
Systolic Heart Failure, Ventricular Premature Complexes, Ventricular Tachycardia, Cardiac Resynchronization Therapy, Reduced Biventricular Pacing

Intervention / Treatment
-----------------
* Procedure: Catheter ablation of ventricular arrhythmia
* Drug: Intensified medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reduced biventricular pacing <98% due to ventricular arrhythmia Exclusion Criteria: reduced biventricular pacing <98% due to other cause age <18 pregnancy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Catheter ablation group<br>Patients with reduced biventricular pacing due to PVC or VT receiving catheter ablation of PVC/VT according to guidelines and clinical practices | Procedure: Catheter ablation of ventricular arrhythmia<br>* PVC or VT ablation<br>|
| Medical treatment group<br>Patients with reduced biventricular pacing due to PVC or VT receiving intensified medical therapy (antiarrhythmics/betablocker) according to guidelines and clinical practices | Drug: Intensified medical therapy<br>* Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Biventricular pacing | Influence of intervention (Ablation/medical treatment) on previously reduced biventricular pacing percentage (<98%). Biventricular pacing is measured in percentage of stimulation and is monitored at routine device interrogation. | 3 month after intervention biventricular pacing (%) is routinely monitored |
A Prospective Study of Radiation Exposure to Surgeons

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.

Detailed Description
-----------------
The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine. The amount of radiation that the Surgeons will be exposed to will be recorded by a ring dosimeter located on the Surgeons' hand, and two badge dosimeters (one above the scrub collar, and one underneath a lead gown at waist level).

Official Title
-----------------
A Prospective Study of Radiation Exposure to Surgeons

Conditions
-----------------
Radiation Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
This study will only enroll the Surgeons of the Vanderbilt Hand and Upper Extremity Center. There will be no inclusion/exclusion criteria for the type of surgery that will be monitored, nor the patients that are having surgery. If a mini c-arm fluoroscopy is used the amount of radiation received by the Surgeon's hand for that surgery will be monitored by a gas-sterilized radiation ring dosimeter. The amount of scatter radiation the Surgeon will be exposed to will be recorded by a badge dosimeter located on the Surgeon's scrub collar, and one badge dosimeter that will be located under the required lead gown worn by the Surgeon.
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation, Exposure, Hand, Orthopaedic, Surgeons
Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to gain more knowledge about the association between muscle weakness, spasticity and motor control in children with cerebral palsy, and its relationship to hand function.

Official Title
-----------------
Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin A
* Behavioral: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed spastic hemiplegic or diplegic cerebral palsy, reduced handfunction. Indication for treatment with Botulinum Toxin A Score 3 on House Classification of Upper-Extremity Functional Use Score 3 or better on Manual Ability Classification System Exclusion Criteria: surgery within the last two years Treatment with Botulinum Toxin within the last six months

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BoNT A<br>Botulinum toxin A injections in muscles of the arm (biceps brachii and brachialis) | Drug: Botulinum Toxin A<br> <br> * Other names: BoNT A;|
| Experimental: Resistance training<br>8 weeks resistance training | Drug: Botulinum Toxin A<br> <br> * Other names: BoNT A;Behavioral: Resistance training<br> <br> * Other names: Strength training;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prostate Cancer Risk in Firefighters

Study Overview
=================
Brief Summary
-----------------
Firefighters have been shown to be at increased risk for various types of cancer, including prostate cancer. This study will try to explore possible reasons for this increase in risk. A study group at the Cancer Registry of Norway is creating a cohort of Norwegian firemen employed from 1960 onwards. A job exposure matrix (JEM) is also being constructed, examining different types of exposure to potentially cancer-inducing agents and activities, and how these have changed historically. Examples include exposure to fire-smoke, shiftwork, diesel exhaust and regular health check-ups. By linking the cohort with data from the Cancer Registry of Norway and the JEM the investigators can examine which exposure assessments, if any, are related to an increased risk of prostate cancer.

Official Title
-----------------
Prostate Cancer Risk in Firefighters: Its Association to Qualitative and Quantitative Indicators of Exposure

Conditions
-----------------
Prostatic Cancer

Intervention / Treatment
-----------------
* Other: Observational study, prostate cancer is outcome of interest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Work as firefighter as recorded by the participating fire stations Exclusion Criteria: Any other occupation, including chimney sweepers
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Firefighters<br> | Other: Observational study, prostate cancer is outcome of interest<br>* Observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of prostate cancer | As reported to the Cancer Registry of Norway | From January 1st 1960 until December 31st 2018 |
Magnetic Resonance Elastography in Infants

Study Overview
=================
Brief Summary
-----------------
MRI & MRE in infants

Detailed Description
-----------------
The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.

Official Title
-----------------
Magnetic Resonance Elastography in Infants

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Device: MRI with MRE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants < 6 months of age Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age) Parental/LAR permission obtained Exclusion Criteria: Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology Severe coagulopathy (INR > 3 or platelets <50,000)

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Magnetic resonance elastography on infants with suspected liver disease
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI with MRE<br>Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device | Device: MRI with MRE<br>* Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population | To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mre, mri, neonatal, liver, mr touch
Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics

Study Overview
=================
Brief Summary
-----------------
The surgically-harvested eye tissue (ie. vitreous-retinal proliferative membrane, outflow pathway, retinas, and pterygium) is a complex tissue responsible for maintaining intraocular homeostasis or mediating ocular pathogenesis. Dysfunction of one or more resident cell types within the tissues results in different ocular disorder, leading to vision loss, or even blindness. In this study, we aim to use single-cell RNA sequencing to generate a comprehensive cell atlas of surgically-harvested eye tissues.

Official Title
-----------------
Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics

Conditions
-----------------
Glaucoma, Diabetic Retinopathy, Proliferative Vitreoretinopathy, Pterygium

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ocular diseases and require surgery intervention. The surgery intervention remove pathological tissue during surgery. Patients consent to the treatment and single-cell sequencing. Exclusion Criteria: 1. Surgically removed eye tissue cannot meet with the quality control of single-cell sequencing (mainly the tissue weight and cell counts);

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgically-removed eye tissue<br> | Procedure: ocular surgery<br>* surgery to remove the pathological eye tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| counts of each cell type | single-cell sequencing identify what cells and the counts within the eye tissue | 1 month |
Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of ALK-001 (C20-D3-retinyl acetate) on the progression of Stargardt disease. This study is an extension of NCT02402660 and enrolls participants who are at least 8 years old. Enrollment is by invitation only. Funding Source - FDA OOPD

Official Title
-----------------
A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

Conditions
-----------------
Stargardt Disease, Stargardt Macular Degeneration, Stargardt Macular Dystrophy, Autosomal Recessive Stargardt Disease 1 (ABCA4-related)

Intervention / Treatment
-----------------
* Drug: ALK-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Simplified Inclusion Criteria: Clinical diagnosis of Stargardt disease (STGD1) Has at least two ABCA4 disease-causing mutations, unless authorized by sponsor Has a best-corrected visual acuity (BCVA) greater than approximately 20/160 in at least one eye Healthy as judged by investigator Able and willing to comply with study requirements, restrictions and instructions and is likely to complete the 24-month study Has been invited to participate in this extension, and has signed and dated the informed consent forms (or assent where appropriate) to participate Female of childbearing potential has signed the attestation on contraception requirements Simplified Exclusion Criteria: Is lactating or pregnant Has a medical condition likely to prevent compliance with the protocol and/or interfere with absorption of ALK-001 or performance of study procedures Has abnormal laboratory result(s) at screening Has an ocular disorder that may confound ocular assessments Has a history of ocular intervention within 90 days of screening

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALK-001<br> | Drug: ALK-001<br>* Oral administration of a pill for up to 24 months<br>* Other names: C20 Deuterated vitamin A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ALK-001 assessed by incidence and/or clinically-significant changes of a combination of ocular and non-ocular adverse events |  | From baseline to 24 months | 
| Pharmacokinetic profile of ALK-001 derived from the concentrations of ALK-001 and metabolites in plasma |  | Up to 24 months |
Exercise and Muscle Protein Signalling

Study Overview
=================
Brief Summary
-----------------
This study examines the muscle protein signalling response after resistance and endurance exercise. We hypothesize that the signalling response after endurance and resistance exercise will be partly similar.

Official Title
-----------------
The Impact of Resistance Versus Endurance Exercise on the Muscle Protein Signalling Response

Conditions
-----------------
Muscle Protein Synthesis

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men inactive Exclusion Criteria: enrolled in a endurance and/or resistance training program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: exercise|1 hour of endurance or resistance exercise|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in phosphorylation of different signalling proteins in the cascade towards protein synthesis |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, muscle protein signalling, protein synthesis