linjc16/ctgov huggingface dataset:
Natural History Study of Usher Syndrome ( Light4Deaf )

Study Overview
=================
Brief Summary
-----------------
Clinical centres in the LIGHT4DEAF consortium have developed and will continue to improve a reliable, early molecular diagnosis and protocols for full clinical characterisation of Usher syndrome, which will be valuable for the foreseen USH clinical trials. The clinical arm of the project aims at performing a deep-phenotyping of retinal degeneration, hearing loss, vestibular dysfunction, neurocognitive ability of subects with a molecular diagnosis of any Usher syndrome. Functional and structural parameters for retinal, auditory, and vestibular impairments are followed overtime to document the natural history of the disease and establish relevant clinical endpoint for disease progression that may be useful for future clinical trials.

Detailed Description
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Our cohort study aims at precisely documenting ophthalmic, auditory, vestibular, cogninitive alterations over time with phenotype/genotype correlation Ophthalmological assessment; Best corrected visual acuity, kynetic perimetry, microperimetry, colour contrast sensitivity, retinal multimodal imaging (fundus photograph, fundus autofluorescence, SD-OCT, OCTA, adaptive optics) ENT assessment: Tone and voice audiometry, Distortion product otoacoustic emissions Language assessment for children Vestibular assessment: Complete assessment of vestibular, canal and otolithic function Neuro-cognitive and visio spatial assessment Genetic: deep-genotyping using next generation sequencing

Official Title
-----------------
Natural History Study of Usher Syndrome in a Cohort of Patients Followed Longitudinally for 5 Years

Conditions
-----------------
Usher Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a molecular diagnosis of Usher syndrome type I, II or III or a clinical diagnosis of Usher syndrome type I, II or III which will then be confirmed by a molecular diagnosis Health insurance beneficiary Informed consent signed by the patient or their legal representatives Exclusion Criteria: • Patient or his/her legal representatives unable to understand the study and for whom informed consent cannot be obtained
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 |
| --- | --- | --- |
| 5-year natural history of Usher syndrome | Phenotype/genotype correlation, structure function correlation and progression of structural and functional parameters | From date of inclusion until the date of last documented progression , assessed up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Usher syndrome,, Natural history study for retinal degenetation,, Deep-phenotyping,, Hearing loss,, Vestibular dysfunction
Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.

Official Title
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Preoperative Evaluation of Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

Conditions
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Adenocarcinoma of Head of Pancreas

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients with (or suspected) pancreatic head cancer Being examined by contrasted-enhanced MDCT Receiving surgical treatment (including palliative surgery) in all research centers Exclusion Criteria: Patients having (or suspected) pregnancy or breast-feeding Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs) Patients receiving ERCP before contrasted-enhanced MDCT examination Patients without surgery because of a high degree of surgical risk
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computed tomography, Contrast enhancement, Pancreas, Cancer, Resectability
MEtatastic Renal Carcinoma LINes

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study are as follows: Prognostic evaluation of patients based on an integrative model provides better assessment of overall survival, and thus improves setting of care goals. In a routine care population, antitumour drugs may have a significant impact on overall survival through their targeted antitumor effect, but also through their toxicity profile and their impact on comorbidities. The optimization of patient support (supportive care, drug tolerance monitoring) can have an impact on the prognosis.

Official Title
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Pronostic Assessment of Mortality Among Locally Advanced or Metastatic Renal Cell Carcinoma Patients After First Line Treatment : Multicenter Prospective Cohort Study With Historic Medical Data

Conditions
-----------------
Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with locally advanced or metastatic renal cell carcinoma Whose first-line treatment included at least one anti-angiogenic agent (tyrosine kinase inhibitor or monoclonal antibodies) and / or an mTOR inhibitor; Whatever was the overall ECOG-PS score (Eastern Cooperative Oncology Group Performance Status) at treatment initiation time With first-line treatment carried out between 2007 and June 2016. Exclusion criteria: Patient previously treated with only one cytokine (Interferon α2a, high-dose interleukin-2) Refusal of processing of personal data

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Overall survival after the first line of treatment | Time elapsed between initiation date for 2nd line treatment et the date of death, whatever the cause. | year 11 |
OneTouch Verio Flex System Accuracy Evaluation

Study Overview
=================
Brief Summary
-----------------
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

Detailed Description
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Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.

Official Title
-----------------
OneTouch Verio Flex System Accuracy Evaluation

Conditions
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Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: OneTouch Verio Flex Blood Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
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Summary of Inclusion Criteria: All Subjects must be registered into the LFSS Patient Registry to participate in the study. Each Participant must read and sign the approved Informed Consent Form. Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy. Summary of Exclusion Criteria: > Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Diabetes<br>One group consisting of diabetic subjects | Device: OneTouch Verio Flex Blood Glucose Monitoring System<br>* Blood Glucose Monitoring System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To meet the requirements of ISO 15197:2015 | In order to meet the requirements of ISO 15197:2015 For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals < 5.55 mmol/L (< 100 mg/dL) or within + 15 % at glucose concentrations > 5.55 mmol/L (> 100 mg/dL). 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes. | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Glucose Monitor System Accuracy
Assessing Repeat Fit Testing for CRC

Study Overview
=================
Brief Summary
-----------------
This study will randomly assign 220 men and women to either a social media intervention or a standard reminder system to have a repeat screening test for colo-rectal cancer.

Detailed Description
-----------------
Only persons initially screening by FIT (through a Rural Cancer Prevention Center service program) will be eligible for study participation. The objective is to test a social media-based intervention designed to promote annual repeat colo-rectal cancer screening using the Fecal Immunochemical Test (FIT) among person who have taken the FIT test once before. 220 men and women (50 to 75 years of age) will be recruited and randomly assigned to either the intervention condition (monthly social media contact) or a control condition (standard of care reminder for repeat testing one month before the annual test is due). The dependent variable will be whether volunteers requested and retuned a FIT kit with 60 days of the annual due date (one year from their initial screening).

Official Title
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Assessing Repeat Annual FIT Screening for Colo-Rectal Cancer (CRC)

Conditions
-----------------
Colo-rectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Now I'm Telling You


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have completed and returned an initial FIT kit to us as part of a Rural Cancer Prevention Center service program to the community Exclusion Criteria: visible blood in stool or prior diagnosis of cool-rectal cancer

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention media condition<br>monthly social media contact will be used to keep people connected to the idea of completing a second screening test 12 months after their last one. | Behavioral: Now I'm Telling You<br>* Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.<br>|
| No Intervention: control condition<br>this group will receive only a standard reminder for the annual repeat test, one month before the test due date | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test | the endpoint is a received completed FIT kit | 15 months |
Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to prospectively evaluate whether markers of a patient's systemic inflammatory response in addition to FDG-PET/CT metabolic parameters of the primary tumor or of nodal metastases can predict radioresistance and survival before primary radiochemotherapy in advanced head and neck cancer patients.

Detailed Description
-----------------
This study prospectively investigates pretherapeutic markers of systemic inflammatory response (including neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, systemic inflammation response index, and systemic immune-inflammation) and FDG-PET/CT-derived metabolic parameters of tumor and nodal metastases (including maximum standardized uptake value, metabolic tumor volume, and total lesion glycolysis) and their potential prognostic value in head and neck cancer patients prior to primary radiochemotherapy.

Official Title
-----------------
Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?

Conditions
-----------------
Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Radiation: Radiochemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histopathologic diagnosis of squamous cell carcinoma of the head and neck primary radio(chemo)therapy with curative intent available pretherapeutic FDG-PET/CT imaging available pretherapeutic differential blood analysis Exclusion Criteria: other tumor entities of the head and neck including cutaneous squamous cell carcinoma primary surgical treatment ongoing infections or other inflammatory diseases at the time of diagnosis patients not completing a course of irradiation with at least 66 Gray locally

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

| Intervention/Treatment |
| --- |
|Radiation: Radiochemotherapy|Primary radiotherapy of the primary tumor and nodal basin with curative intent with or without concomitant chemotherapy with cisplatin, carboplatin, or cetuximab weekly.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall survival, disease-specific survival, local and regional recurrence-free survival, and distant metastasis-free survival | Prospective analysis of various measures of survival up to 5 years after completion of the therapy. Events such as tumor recurrence or death will be recorded continually. |
Maturation of the Autonomic Nervous System in Prematures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.

Detailed Description
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To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.

Official Title
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Maturation of the Autonomic Nervous System in Prematures

Conditions
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Analysis, Event History

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All prematures

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 100 Days

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 |
| --- | --- | --- |
| Herat rate variability (HRV) characteristics | It is well known that maturation of the autonomic nervous system can be detected by heart rate variability in children. The purpose of this study is to apply HRV characteristics in premature infants and try to evaluate if there are noticable changes in these parameters both in healthy and diseased premature infants longitudinally during their stay at the NICU. Outcome measures to be studied are very low frequency ( VLF), low-frequency ( LF), high frequency (HF) frequency bands in the power spectrum density (PSD) of HRV records. | 3 years |
Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are as follows: to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity. to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma. to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery. to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.

Official Title
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Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma

Conditions
-----------------
Skull Injury Trauma

Intervention / Treatment
-----------------
* Procedure: microscope surgery
* Procedure: neuroendoscope surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Skull Base Trauma Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: microscope surgery|nan|
|Procedure: neuroendoscope surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 1 year | 
| disability rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skull Base Trauma, microscope surgery, neuroendoscope surgery
Referral Recommendations for Axial Spondyloarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.

Detailed Description
-----------------
Ankylosing spondylitis (AS) and its early form accounts for up to 5% of all patients with chronic back pain. Shortening the delay of 5-10 years between first symptoms and making a diagnosis of AS has become a challenge especially because effective treatments have become available. Easy to apply referral parameters for physicians in primary care may contribute to make the diagnosis earlier. Methods: Orthopedists and primary care physicians were offered to refer patients with i) chronic low back pain (duration >3 months) and ii) onset of back pain at an age < 45 years to a specialized rheumatology outpatient clinic for further diagnostic work-up if at least one of the following screening parameters was present: 1) inflammatory back pain (IBP), 2) positive HLA-B27, 3) sacroiliitis as detected by imaging. The final diagnosis was made according to expert opinion. It was analyzed, which parameters or combination of parameters performed best in making a diagnosis of axial SpA.

Official Title
-----------------
Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis

Conditions
-----------------
Ankylosing Spondylitis, Spondyloarthropathy, Spondyloarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic back pain with a duration of more than 3 months onset of back pain before age of 45 years Exclusion Criteria: age younger than 18 years

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

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
-----------------
pre-radiographic, screening, early diagnosis
The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment

Study Overview
=================
Brief Summary
-----------------
The chronic obstructive pulmonary disease (COPD) patients with type II respiratory failure always needs PaCO2 test to monitor the changes of disease. Method used mostly nowadays to detect PaCO2 is arterial puncture which is accurate but is invasive, painful and non-dynamic. Noninvasive measurement methods includes end-tidal CO2 (PetCO2), transcutaneous CO2 (PtcCO2) which can monitor the PaCO2 dynamically and noninvasively, but their accuracy is in controversy. Common PetCO2 is especially inaccurate in COPD patients while our team find that the accuracy can be improved by prolong expiration method (PetCO2 (P)).So the investigators want to compare the accuracy of PtcCO2 and PetCO2(P) in AECOPD patients during noninvasive ventilation(NIV).

Official Title
-----------------
The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment

Conditions
-----------------
COPD

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AECOPD patients with type II respiratory failure who need NIV treatment Exclusion Criteria: hemodynamics is unstable; any other lung disease despite COPD; other diseases influencing experiments: Cognitive impairment disease mouth and nose trauma.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| AECOPD group<br>The study incruit AECOPD patients with type II respiratory failure who need the NIV treatment. | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial arterial pressure of end-tidal CO2 measured by prolong expiration method [PetCO2(P)] | PetCO2(P) will be measured before and after NIV treatment. | 2 hours | 
| partial arterial pressure of transcutaneous CO2 (PtcCO2) | PtcCO2 will be measured before and after NIV treatment. | 2 hours | 
| partial arterial pressure of carbon dioxide (PaCO2) | PaCO2 will be measured before and after NIV treatment. | 2 hours |