linjc16/ctgov huggingface dataset:
Retrospective Study of Psychoattitudinal Patterns in Patients With Fibromyalgia Receiving Antalgic Therapy

Study Overview
=================
Brief Summary
-----------------
Fibromyalgia (FM) is a widespread and invalidating disease that requires a multidisciplinary approach. Particularly, the psychiatric component seems to influence the algological management of these patients. Since January 2018, the HADS, SF-36, IMSA, TCI psycho-attitudinal questionnaires have been introduced in the Pain Therapy unit of Policlinico Sant'Orsola-Malpighi in an attempt to improve the care of patients diagnosed with FM. The aim of the study is to identify, through retrospective evaluation of TCI tests and its subdomains, compiled by patients with FM diagnosis, Pain Avoidance and Pain Persistance personality patterns, indicated in the literature. Anxiety and Depression incidence is also observed through retrospective evaluation of HADS tests. Patients in the Antalgic Therapy Outpatient Clinic diagnosed with FM, aged ≥18 years, who have completed selfadministered psychoattitudinal tests from January 2018 to January 2019 were considered. The data were collected in aggregate and extrapolated anonymously.

Official Title
-----------------
A Retrospective Study Concerning the Psycho-attitudinal Classification of Patients Suffering From Fibromyalgia Undergoing a Specialized Analgesic Treatment

Conditions
-----------------
Analgesia, Fibromyalgia, Pain, Chronic, Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of fibromyalgia years ≥ 18 Exclusion Criteria: not present

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 |
| --- | --- | --- |
| Psycho-attitudinal Pattern | A retrospective evaluation of the Temperament and Character Inventory test scores in the period from January 2018 to January 2019 by patients diagnosed with Fibromyalgia related to the antalgic therapy clinic. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and depression | To investigate the presence of moderate to severe anxiety-depressive disorders among patients with anxiety and depression at the antalgic therapy clinic using the HADS tool. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Pain, Chronic, Analgesia
Vaccine Attitudes and Practices of Hospital Specialists

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the perceptions and knowledge of hospital specialists regarding vaccine recommendations targeting their patients, to study their behavior with respect to these recommendations and to quantify their vaccine hesitancy.

Official Title
-----------------
Vaccine Attitudes and Practices of Hospital Specialists

Conditions
-----------------
Vaccine Practice

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be a physician in one of the participating institutions Or to be a contract physician in participating institutions Exclusion Criteria: Interns Attached practitioners Emergency physicians
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Questionnaire|a 15min questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of Hospital Specialists (HS) with knowledge of vaccine recommendations targeting their patients |  | 15 minutes | 
| Proportions of HS regularly recommending recommended vaccines to their patients |  | 15 minutes | 
| Proportions of HS with doubts about recommended vaccines |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Link between perception of benefits and risks of vaccines, knowledge of vaccine-preventable diseases, trust in different sources of information and vaccine hesitancy will be measured by questionnaire (measure by multiple logistic regressions) |  | 15 minutes | 
| Measure of attitudes and practices of HS vis-a-vis to vaccination and their specialty by questionnaire | number of HS vaccinator or not by specialty in connection with their attitudes and practices | 15 minutes | 
| Percentages of HS feeling sufficiently trained or confident to explain to patients about vaccines |  | 15 minutes | 
| Percentages of HS claiming to be vaccinated, by type of vaccine |  | 15 minutes | 
| Percentages of HS children reported vaccinated by type of vaccine |  | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccination survey, Vaccine hesitancy, Hospital specialists (HS)
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients

Study Overview
=================
Brief Summary
-----------------
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile. The study takes place during a single visit, at the time of patient enrollment in the study

Official Title
-----------------
A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.

Conditions
-----------------
Haemophilia A

Intervention / Treatment
-----------------
* Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with severe haemophilia A defined as residual factor VIII activity < 1% or Patient with moderate haemophilia A (residual factor VIII activity >1% and <5%) with severe clinical profile Patient treated in prevention with the same plasma or recombinant factor VIII for at least 6 months Patient whose inclusion visit is performed during a routine visit including a measurement of plasma residual factor VIII :c level In the medical file (retrospective data) the pharmacokinetic parameters are available and have been obtained from a PK analysis of factor VIII level performed with the same anti haemophilic factor than the one used on the inclusion day Exclusion Criteria: Patients with haemophilia B
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool |  | after 1 month | 
| The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool |  | after 1 month | 
| The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool |  | after 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dosage of factor VIII calculated by OPTIMS calculator |  | within 48 hours after enrollment | 
| The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire |  | within 48 hours after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilia A, Factor VIII, Pharmacokinetic, Computer Tool validation
Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.

Official Title
-----------------
Open-label Phase 3b Study to Investigate the Safety of Ross River Virus (RRV) Vaccine From 6 to 12 Months After the Third Vaccination in Healthy Adults (Follow up to Precursor Study 880801)

Conditions
-----------------
Prophylaxis of Ross River Virus Infection

Intervention / Treatment
-----------------
* Biological: Ross River Virus (RRV) Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who participated in precursor Study 880801 and meet all of the following criteria: Subject received 3 RRV vaccinations in Study 880801 Subject has completed Visit 6 in Study 880801 Subject and, if applicable, subject´s parent(s)/legal guardian(s), understand the nature of the study and its procedures, agree to its provisions and provide written informed consent prior to study entry Subject provides written assent according to his/her age, if applicable Exclusion Criteria: Subject has participated in another clinical study other than Study 880801 involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Safety assessment<br>Vaccine safety will be assessed in the period between 6 and 12 months after the 3rd vaccination in precursor Study 880801 based on diaries distributed to all subjects for documentation of SAEs or AESI. Females who became pregnant after the 3rd vaccination in Study 880801 will be followed until end of pregnancy. | Biological: Ross River Virus (RRV) Vaccine<br>* Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SAEs and AESI, such as arthritis, Guillain Barré Syndrome (GBS), encephalitis, convulsions, Bell´s palsy, neuritis, vasculitis, demyelinating disorders (ADEM and myelitis) and vaccination failure | SAE = Serious adverse event, AESI = Adverse event of special interest | 12 months after the third vaccination administered in precursor study 880801 |
Microparticles, Vector of Genetic Information During HIV Infection

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators study is to demonstrate in healthy subjects and a cohort of patients infected with HIV, the presence of miRNAs in circulating peripheral blood microparticles (MPs).

Official Title
-----------------
Microparticles, Vector of Genetic Information During HIV Infection ?

Conditions
-----------------
HIV,

Intervention / Treatment
-----------------
* Biological: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 40 +/-10 years Seronegativity for the HIV 2 Patients of the group A: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and having never received from antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml Patients of the group B: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and under stable antiretroviral treatment for at least 6 months, with a viral load undetectable plasmatique (< 40 copies / ml) patients of the group C : Matching on the age (+/-3 years) to a patient Be considered healthy by the Investigator after a clinical examination Seronegativity for the HIV 1 confirmed in ELISA the day of the taking Exclusion Criteria: group A et B Age of < 30 years and > in 50 years Seropositivity for the HIV 2 group C Seropositivity for the HIV 2 - Be under medicinal treatment

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Groupe A<br>Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml | Biological: Blood samples<br> <br> |
| Experimental: group B<br>Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml | Biological: Blood samples<br> <br> |
| Placebo Comparator: group C<br>Healthy volunteers | Biological: Blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NUMBER OF miRNAs |  | 2 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the presence of miRNAs in microparticles |  | 2 YEARS |
Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Weeks

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: NAB001
* Drug: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate fungal infection of the toenail as assessed by study doctor koh positive & dermatophyte culture positive at Visit 1 general good health as assessed by study doctor Exclusion Criteria: severe fungal toenail infection prior use of antifungal drugs (wash-out allowed, duration varies on class) significant confounding conditions as assessed by study doctor pregnancy/lactation must forego nail salon procedures during study for at least  60 weeks

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active drug<br> | Drug: NAB001<br>* nail lacquer, once daily, 52 weeks<br>|
| Placebo Comparator: Vehicle alone<br> | Drug: Placebo control<br>* nail lacquer, once daily, 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. |  | Week 56 after 52 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear). |  | Week 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toenail fungus, onychomycosis, nail infection
Role of Bile Duct Resection in Major Hepatectomy Due to Intrahepatic Cholangiocarcinoma

Study Overview
=================
Brief Summary
-----------------
To investigate the prognosis due to presence or absence of bile duct resection in intrahepatic cholangiocarcinoma that require hepatic lobectomy.

Detailed Description
-----------------
The bile duct resection in hepatic lobectomy due to cholangiocarcinoma, mass forming type, is still controversial. We retrospectively evaluated the effect of bile duct resection in this surgery.

Official Title
-----------------
Role of Bile Duct Resection in Major Hepatectomy Due to Intrahepatic Cholangiocarcinoma

Conditions
-----------------
Intrahepatic Cholangiocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of major hepatectomy due to intrahepatic cholangiocarcinoma Exclusion Criteria: -
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 |
| --- | --- | --- |
| 3-year recurrence-free survival rate |  | 11 years (2000-2010) | 
| Ratio of local recurrence at the hepatico-duodenal ligament |  | 11 years |
Postpartum Diabetes Screening in Women With Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in the postpartum period

Official Title
-----------------
Active Management of Postpartum Diabetes Screening After Gestational Diabetes: a Randomized Controlled Trial

Conditions
-----------------
Diabetes, Gestational

Intervention / Treatment
-----------------
* Behavioral: Reminder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GDM, english speaking - Exclusion Criteria: Non english speaking. Younger than 18 years of age -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active management<br>Laboratoy test request given postpartum with phone reminder prior to test | Behavioral: Reminder<br> <br> |
| No Intervention: Routine care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum Diabetes screening in GDM patients |  | 1 year |
Comparison of Two Sedation Versus Placebo Techniques During Cataract Surgery Under Local Anesthesia

Study Overview
=================
Brief Summary
-----------------
Check the sedation conditions during topic cataract surgery

Official Title
-----------------
Comparison of Two Sedation Versus Placebo Techniques on the Patient's Intraoperative Comfort During Cataract Surgery Under Local Anesthesia

Conditions
-----------------
Sedation, Cataract

Intervention / Treatment
-----------------
* Drug: Cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Topic cataract surgery Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Other: Sufentanil sedation<br>3 microgram of Sufentanil IV | Drug: Cataract surgery<br>* Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery<br>|
| Placebo Comparator: Placebo sedation<br>1 ml de NaCl 0,9% | Drug: Cataract surgery<br>* Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery<br>|
| Other: Multimodal sedation<br>Clonidine, sufantil, midazolam, dihydrobenzperidol, ketamine | Drug: Cataract surgery<br>* Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction: four Lickert's scales | The patient's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome) | During cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon's satisfaction: four Lickert's scales | The surgeons's satisfaction was assessed by four Lickert's scales, ranging from one (worse outcome )to four (better outcome) | During cataract surgery | 
| hemodynamic parameters | The hemodynamic parameters was rated before incision, 10min after incision and at the end of surgery | Durinf cataract surgery |