linjc16/ctgov huggingface dataset:
Dual Algorithm Post Market Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

Detailed Description
-----------------
This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.

Official Title
-----------------
Evaluation of the MP Diagnostics HTLV Blot 2.4

Conditions
-----------------
HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1, Human T-lymphotropic Virus 2, HTLV I Associated T Cell Leukemia Lymphoma, HTLV I Associated Myelopathies

Intervention / Treatment
-----------------
* Diagnostic Test: MP Diagnostics HTLV Blot 2.4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Completion of a health history evaluation for routine donor screening Provided a routine blood donation Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay Exclusion Criteria: Unwilling or unable to provide informed consent to blood donation Inadequate sample volume for testing Unable to provide samples that meet the suitability requirements for testing

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 |
| --- | --- |
| HTLV Repeat Reactive (RR) / Non Reactive (NR)<br>Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay | Diagnostic Test: MP Diagnostics HTLV Blot 2.4<br>* HTLV I/II Confirmation and Differentiation<br>* Other names: HTLV I/II Western Blot Assay;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the HTLV dual algorithm testing in blood donor facilities | HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II
Participation Restrictions in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate what factors contribute to social participation restrictions in subjects with Rheumatoid Arthritis (RA), considering the model International Classification of Functioning (ICF). Methods: Cross-sectional study with 81 individuals with Rheumatoid Arthritis, using instruments to measure two constructs of component social participation.

Detailed Description
-----------------
In this study the definition of social participation considered several areas, such as marriage and family, work, leisure, religion, economy, and politics which are based in the social scales of the questionnaires SF-36 and AIMS2.

Official Title
-----------------
Factors Associated With Participation Restrictions in Individuals With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years of age Mental capacity as assessed by the Brazilian version of Mini Mental State Examination Diagnosis of RA according to the American College of Rheumatology (ACR) 1987 criteria established by attending service rheumatologist. Exclusion Criteria: Individuals who had undergone surgery of the upper limbs, were unable to comply with the protocol for data collection, or with non-corrected visual deficits that could interfere with their functionality were excluded

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational study|application of several standard instruments in patients with rheumatoid arthritis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short Form Instruments (social aspect) and Arthritis Impact Measurement Scale (social interaction) were used as outcome measures to assess the social participation according to the International Classification of Functioning, Disability and Health | We evaluated 81 individuals in a single meeting with the SF-36 and AIMS2, each participant was assessed for 2 hours. The revised AIMS2 comprises five main dimensions. The score of each AIMS scale varies from zero to 10 (a score of 10 indicates the worst state of health). The SF-36 is a generic instrument that assesses quality of life and comprises eight dimensions. The SF-36 final score varies from zero to 100 in each of the eight dimensions (a score of 100 represents the best state of health). | June 2009 to August 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
social participation, International Classification of Functioning
Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors

Study Overview
=================
Brief Summary
-----------------
Study with two arms, one of which receives an intervention in the form of participative artistic workshops at the MAMAC and the other was assigned as the control group. Well-being, Quality of life, Health, Apathy and Olfactory identification scales are proposed before the intervention, during the intervention at the end of each month (M1, M2, M3), 6 months after the end of the intervention (M9) and 12 months after the end of the intervention (M15).

Official Title
-----------------
Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors

Conditions
-----------------
Well Aging

Intervention / Treatment
-----------------
* Other: Artistic activies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 65 years of age at the time of signing the consent, Having internet access and an electronic tool (smartphone and/or tablet) at home as repeated assessments will be proposed on a dedicated and secure internet platform, To master the French language, To be available during participatory workshop sessions at MAMAC. Be affiliated to Social Security Exclusion Criteria: Do not master the French language, Severe sensory and/or cognitive impairment identified by the IP and their representatives during the inclusion interview, Person under guardianship, curatorship or safeguarding of justice, Person unable to give or sign consent.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: artistic activities<br>participants will do a 3-month cycle of weekly artistic activities at the MAMAC Museum, which are structured 2-h-long art-based workshops | Other: Artistic activies<br>* 12 workshops of artictic activities during 12 weeks<br>|
| No Intervention: No artistic activities<br>The control group is composed of participants who do not take part in art-based activities, | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of well being level | well being scale assessment Warwick-Edimbourg Mental Well-Being State (WEMWBS) maximum value : 70 (better outcome) minimum value :14 (worse outcome) | before the intervention, during the intervention at the end of each month (Month1, Month 2, Month 3), 6 months after the end of the intervention (Month 9) and 12 months after the end of the intervention (Month 15) |
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery

Study Overview
=================
Brief Summary
-----------------
Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.

Detailed Description
-----------------
compare the patient-selected NOSE method and conventional method in laparoscopic total colon surgery

Official Title
-----------------
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery

Conditions
-----------------
Surgical Incision

Intervention / Treatment
-----------------
* Procedure: natural orifice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic total colectomy patients Exclusion Criteria: no

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: natural orifice<br>Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled | Procedure: natural orifice<br>* laparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather<br>* Other names: conventional;|
| No Intervention: conventional<br>patients who underwent laparoscopic surgery and removed specimen with conventional will be gathered. demographic data and perioperative results will be compiled. (conventional extraction is suprapubic or median incision) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score | Visual Analog Score for pain (1-10 score) | 240 days |
Myeloproliferative Neoplastic Diseases Observatory From Brest

Study Overview
=================
Brief Summary
-----------------
All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study. Myeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis. This is a not interventional study. Alive patients need to sign a non-opposition consent form. Patients will be followed until last news (death, change of reference centre...).

Detailed Description
-----------------
In this retrospective and prospective study, clinical and biological data from diagnosis until last news will be recorded. Clinical data collected: patients and disease characteristics at the time of the diagnosis, disease and mutational status, cardio-vascular risk factors, history of thrombosis and cancer. Biological data collected: hemogram and bone marrow results if available. During the follow-up new data will be noted: treatment changes (reasons of change and type of drug), thrombotic events (localization, date and hemogram), phenotypic evolutions (type and date), death (date and etiology).

Official Title
-----------------
Observatoire Brestois Des Néoplasies Myéloprolifératives

Conditions
-----------------
Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essentiel thrombocythemia, polycythemia vera or primary myelofibrosis Signature of the non-opposition consent form Exclusion Criteria: None
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 | occurrence of death | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of evolutions | occurrence of transformation into polycythemia vera, secondary myelofibrosis, myelodysplastic syndrome or acute leukemia | 10 years | 
| Incidence of thromboses | occurrence of arterial or venous thrombotic events | 10 years |
OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

Study Overview
=================
Brief Summary
-----------------
Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH. In this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.

Conditions
-----------------
Pediatric Idiopathic Intracranial Hypertension

Intervention / Treatment
-----------------
* Other: OCT Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with suspected IIH Exclusion Criteria: Retinal disease High refractive error Unable to undergo OCT imaging

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IIH Patients<br>Patients diagnosed with Idiopathic Intracranial Hypertension who undergo OCT imaging | Other: OCT Imaging<br> <br> |
| Active Comparator: Control Group<br>Patients diagnosed with headache with ruled out Idiopathic Intracranial Hypertension who undergo OCT imaging | Other: OCT Imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of RNFLT/TRT Thickness |  | One year |
Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the experiences and needs of patients with a high-grade glioma and their caregivers. Semi-structured interviews with patients and caregivers will be conducted and analysed using Grounded-Theory approach.

Official Title
-----------------
Experiences and Needs of Patients With a High-grade Glioma and Their Caregivers

Conditions
-----------------
Brain Neoplasms, Primary Malignant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Patients with a primary high-grade glioma who are treated with chemo or were treated with chemo Caregivers of patients with a primary high-grade glioma who are treated with chemo or were treated with chemo Able to be interviewed Dutch Exclusion Criteria: Patients with cerebral metastases Patients and caregivers who withdraw their informed consent Emotionally and cognitive not being able to be interviewed

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 |
| --- | --- | --- |
New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure

Study Overview
=================
Brief Summary
-----------------
Patients admitted to Intensive Care Unit often are affected by acute respiratory failure at admission or during hospital stay, with a mortality of 30%. Treatment remains largely supportive with mechanical ventilation as the mainstay of management by improving the hypoxemia and reducing the work of breathing; however, the mechanical forces generated during ventilation can further enhance pulmonary inflammation and edema, a process that has been termed ventilator induced lung injury (VILI). Consequently, in clinical practice the lung protective ventilation is mainly based on the reduction of the tidal volume, the airway and the transpulmonary plateau pressure. A good clinical practice is based on the assessment of changes in respiratory mechanics. Aim of the study is to determine the accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use in our Operative Unit.

Official Title
-----------------
Validation of a New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure During Invasive Mechanical Ventilation in Patients With Acute Respiratory Failure

Conditions
-----------------
Acute Respiratory Failure, Ventilator-Induced Lung Injury

Intervention / Treatment
-----------------
* Device: OPTIVENT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute respiratory failure invasive mechanical ventilation. Exclusion Criteria: haemodynamic instability presence of barotrauma esophageal disease.

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 |
| --- |
|Device: OPTIVENT|OPTIVENT (SIDAM SRL, Mirandola, Italy) is a new fully automated and self-calibrating system that allows a real-time monitoring and recording of airway pressure and esophageal pressure during mechanical ventilation. The system required the insertion of an esophageal balloon catheter and an airway pressure transducer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of transpulmonary pressure (cmH2O). | Validation of the new system in terms of accuracy and precision. The accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use, will be assessed by measure of airway and esophageal pressure at the end of an inspiratory and expiratory hold. | Day 1. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Respiratory Mechanics, Transpulmonary pressure, Pleural pressure
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.

Official Title
-----------------
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

Conditions
-----------------
Cervical Spine Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any participant less than 18 years old after blunt trauma Seen by trauma service With cervical spine imaging (XR, CT, or MRI) Exclusion Criteria: CT scan from outside facility is poor quality and not repeated (<63-channel, cuts >3mm, no reformats, motion artifact) No radiology over reads by participating institution

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
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 |
| --- | --- | --- |
| Predictive Values of CT, XR, and MRI | The sensitivity, specificity, negative and positive predictive values of CT, XR, and MRI for clinically significant injury will be calculated. | 5 years |