linjc16/ctgov huggingface dataset:
COPD and Cardiovascular Risk in the Population

Study Overview
=================
Brief Summary
-----------------
The prevalence of chronic obstructive pulmonary disease (COPD) in patients with cardiovascular disease (CVD) is unknown, and whether or not COPD is adequately diagnosed and treated in these patients has not been investigated before. We hypothesized that the prevalence of COPD would be significantly higher (30%) in patients with CVD than in the general population. Besides, we anticipated that COPD, a potentially treatable CV risk factor, would be undiagnosed in more than 80% of CVD patients.

Detailed Description
-----------------
We aim to compare clinical and spirometric data in three groups of individuals. Two of them are participants in an ongoing population-based study (CORSAIB) aimed at investigating the distribution of CVD risk factors in the general population of the Balearic Islands, Spain. The design and full methodological details of the CORSAIB study have been published elsewhere (Rigo F, et al. Rev Clin Espa 2005). A third group will include patients with stable CVD regularly visited at the referral hospital of our community. Inclusion criteria for the study are male and female individuals, aged 40 to 81 years, residents of the Balearic Islands, and who are willing to participate in this research.

Official Title
-----------------
COPD and Cardiovascular Risk in the Population

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents of the Balearic Islands willing to participate in this research able to sign the written consent form Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 81 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 |
| --- | --- | --- |
| Prevalence of COPD defined according to the current GOLD guidelines as a post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) <0.7. |  | Current | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Underdiagnosis of COPD |  | Current | 
| Undertreatment of COPD |  | Current | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular, COPD, Population, Prevalence, Underdiagnosis
Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak

Study Overview
=================
Brief Summary
-----------------
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration. In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression. During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients. The present study is an emergency being realize before the end of the quarantine.

Official Title
-----------------
Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak

Conditions
-----------------
Sars-CoV2, Rheumatic Diseases, Rheumatoid Arthritis, Chronic Pain

Intervention / Treatment
-----------------
* Other: questionnaire assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis Quarantine Exclusion Criteria: Non adult patient RA patient without quarantine

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 |
| --- | --- |
| patient with chronic painful inflammatory rheumatism<br> | Other: questionnaire assesment<br>* The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of RA patients with emotional impact (feeling of isolation) |  | maximum 1 week from baseline on | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported questionnaire for painful | Self reported questionnaire with questions to assess the characteristic,intensity of pain on quality of life, and consumption of analgesic. | maximum 1 week from baseline on | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychological impact, COVID-19, Rheumatoid arthritis
Transfer of Standard Operating Procedures in Anesthesiology

Study Overview
=================
Brief Summary
-----------------
Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.

Detailed Description
-----------------
The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.

Official Title
-----------------
Evaluation From Didactic and Structural Transfer of Standard Operating Procedures in Anesthesiology

Conditions
-----------------
Patient Safety

Intervention / Treatment
-----------------
* Other: Audiovisual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: anesthesia residents anesthesia consultants Exclusion: nurses students
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Group<br>Intervention Group with audiovisually blended learning concept | Other: Audiovisual<br>* Receive blended learning before and reading the Standard operating procedure<br>|
| Standard group<br>Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of SOP deviations | SOP deviations during scenario training | 12 minutes after start scenario |
Clinical Safety and Efficacy of CT ASPHINA 509 Lenses

Study Overview
=================
Brief Summary
-----------------
Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation

Official Title
-----------------
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: CT ASPHINA 509


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent; Patients of any gender Assured follow-up examinations Biometry measurement preferably compatible with the IOLMaster evaluation; IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract) Exclusion Criteria: • BCVA not available preoperatively or better than 0.3 logMAR pre-op Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial Patients whose freedom is impaired by administrative or legal order Concurrent participation in another drug or device investigation
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: 509<br> | Device: CT ASPHINA 509<br>* Intraocular lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Monocular best corrected distance visual acuity | 12 to 18 months after surgery |
Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Detailed Description
-----------------
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Official Title
-----------------
Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: CATS Tonometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients, at least 18 years of age Subject has a clear understanding and agrees to all the conditions of the informed consent form Exclusion Criteria: • Subject has undergone ocular surgery within the last 3 months Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk Pregnant or nursing women Those who have had corneal surgery including corneal laser surgery Microphthalmos Buphthalmos Severe Dry eyes Lid squeezers - blepharospasm Nystagmus corneal or conjunctival infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 101 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CATS Tonometer|CATS Tonometer Prism|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP measurement | comparative IOP measurement between CATS and GAT tonometer prisms | 6 months |
Safety Study of FP-1039 To Treat Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.

Official Title
-----------------
A Phase 1, Open-Label, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of FP-1039 in Subjects With Metastatic or Locally Advanced Unresectable Solid Tumors

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: FP-1039


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with metastatic or locally advanced unresectable solid tumors for which standard curative or supportive measures do not exist or are no longer effective Male or female 18 years of age or older Exclusion Criteria: Presence or history of melanoma Primary brain tumor Presence or history of glaucoma

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single ascending doses | Drug: FP-1039<br>* Intravenous weekly administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 4 weeks |
A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

Official Title
-----------------
An Exploratory Evaluation of Interleukin 28B (IL28B) Genotype, Single Nucleotide Polymorphisms (SNP) of rs12356193, Protein and RNA Biomarkers in Serum Samples (Stored, Already Obtained From Completed Studies) From Subjects With HBe-antigen Positive or Negative Chronic Hepatitis B, Who Have Completed Therapy for Hepatitis B With Pegasys ± Lamivudine.

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HBe-antigen positive or negative chronic hepatitis B, and no other chronic viral infections who completed therapy for Hepatitis B with Pegasys ± lamivudine Inclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432 Samples from patients treated with either Pegasys or Pegays + lamivudine are included in this analytical study Samples will only be analyzed for patients where Investigational Review Board approval has been granted Exclusion Criteria: Exclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-28B (IL-28B) genotype in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine |  | Samples up to 72 weeks of treatment | 
| Single nucleotide polymorphisms (SNP) of rs12356193 in stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine |  | Samples up to 72 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-28B concentration at baseline and during treatment with Pegasys +/- lamivudine from stored serum samples of patients with chronic hepatitis B |  | Samples up to 72 weeks of treatment | 
| Protein/RNA biomarker evaluation from stored serum samples of patients with chronic hepatitis B, who have completed therapy with Pegasys +/- lamivudine |  | Samples up to 72 weeks of treatment |
G-CSF in the Treatment of Toxic Epidermal Necrolysis

Study Overview
=================
Brief Summary
-----------------
NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial. Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.

Official Title
-----------------
Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis

Conditions
-----------------
Stevens - Johnson Syndrome

Intervention / Treatment
-----------------
* Drug: recombinant granulocyte - colony stimulating factor
* Drug: NaCl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission Exclusion Criteria: Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission Hypercoagulable state Cardiac or peripheral arterial disease Active malignancy Myelodysplastic syndrome or hematological malignancy Fructose intolerance Pregnancy Patient refusal

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-CSF<br>An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4. | Drug: recombinant granulocyte - colony stimulating factor<br> <br> * Other names: Neupogen (Amgen);|
| Placebo Comparator: Placebo<br>An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4. | Drug: NaCl 0.9%<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for healing | Time for complete cutaneous healing, considered as healing of 90% of the body surface area | From date of randomization until the date of complete healing, assessed up to 30 days. | 
| Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) | Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) | At admission and at day 5 | 
| Biological data: Neutrophilic count | Neutrophilic count | Every day during the 14th first days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological data: WBC count | WBC count | 3 months after discharge | 
| Biological data: WBC formula | WBC formula | 3 months after discharge |
Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer

Study Overview
=================
Brief Summary
-----------------
Microwave ablation (MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate the variability and reproducibility of single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller than 3 cm in patients without underlying liver disease.

Official Title
-----------------
Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible

Conditions
-----------------
Liver Neoplasms

Intervention / Treatment
-----------------
* Device: Microwave ablation
* Device: Radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresectable metastatic liver cancer No invasion of major biliary structures No invasion of major vascular structures ASA score < 4 WHO score 0-1 Pre-operative chemotherapy is allowed Exclusion Criteria: Resectable liver metastases Life expectancy less than 3 months Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials Coagulopathy with platelet count less than 50000 Active infectious disease Age below 18 years Pregnancy of breastfeeding

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MWA<br>Patients undergoing MWA for hepatic metastases smaller than 3 cm, without underlying liver disease | Device: Microwave ablation<br>* Liver tumors are destructed/ablated using single-probe microwave energy device<br>* Other names: MW ablation antenna (VT2237) and a 915 MHz Valleylab MW generator (VTSYS3; Covidien, Europe NV);|
| Active Comparator: RFA<br>Patients undergoing RFA for hepatic metastases smaller than 3 cm, without underlying liver disease | Device: Radiofrequency ablation<br>* Liver tumors are destructed/ablated using radiofrequency energy device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of ablation diameters |  | within the first 7 days and 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignancy, liver, microwave, surgery