linjc16/ctgov huggingface dataset:
NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)

Study Overview
=================
Brief Summary
-----------------
The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body. The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest.

Official Title
-----------------
A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest

Conditions
-----------------
Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: NEURESCUE device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 and ≤80 years CPR initiated within 7 min of presumed arrest 8 min of continuous ACLS without ROSC Exclusion Criteria: Traumatic cardiac arrest Intraoperative cardiac arrest Known pregnancy Known terminal disease Known do-not-attempt-CPR order Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath Subjects currently on mechanical circulatory support

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The NEURESCUE device will be used as an adjunct to ACLS. | Device: NEURESCUE device<br>* The balloon catheter is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful balloon inflation within 10 minutes from first vessel puncture |  | Assessed up to 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central blood pressure |  | Assessed up to 1 hour | 
| Total ACLS time at initiation of the investigational procedure |  | Assessed up to 1 hour | 
| Time from first vessel puncture to successful sheath insertion |  | Assessed up to 1 hour | 
| Rate of occlusion success |  | Assessed up to 1 hour | 
| Return of spontaneous circulation (ROSC) | The endpoint is dichotomous (yes/no) for each subject | Assessed up to 1 hour |
Obstetric and Perinatal Outcomes of Women With COVID-19

Study Overview
=================
Brief Summary
-----------------
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.

Detailed Description
-----------------
Clinical manifestations of COVID-19 can range from a benign upper respiratory tract infection to severe acute respiratory distress syndrome (ARDS), fatal in 1% of cases. However, pregnant women and their fetuses could particularly be vulnerable to the infection, as shown by previous human coronavirus outbreaks (SARS-CoV and MERS-CoV). Cases will be recruited among all pregnant women aged >18 years old who have tested positive for COVID-19 and are followed in a maternity belonging to the French South Regional Perinatology Network. Voluntary physicians will refer eligible participants to the study-coordinating center at APHM University Hospital. The participants will be followed by phone after having provided an informed consent. Clinical symptoms, laboratory and imaging findings, maternal and perinatal outcomes will be recorded.

Official Title
-----------------
Obstetric and Perinatal Outcomes of Women With COVID-19: A Prospective Cohort Study

Conditions
-----------------
Pregnant Women

Intervention / Treatment
-----------------
* Behavioral: Examine the impact of COVID-19 during pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Able to give informed consent Diagnosed with COVID-19 Exclusion Criteria: Patients Refusing to Participate in the Study Patients who do not speak French well enough to benefit from clear and intelligible information

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women with COVID-19<br>Pregnant women who have tested positive for COVID-19 | Behavioral: Examine the impact of COVID-19 during pregnancy<br>* clinical data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the complications rates | To compare the complications rates of pregnant women tested positive for the SARS-CoV-2 (study group), with reference rates in a Covid-free population. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical presentation | To record clinical presentation of pregnant participants with COVID-19 by questionnaire and clinical evaluation | 12 months |
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra

Study Overview
=================
Brief Summary
-----------------
This study will demonstrate if a treatment optimization program has an impact on the satisfaction with Viagra treatment in men with erectile dysfunction

Official Title
-----------------
Effectiveness Of An Educational Program To Improve Patients' Satisfaction Regarding Their Management Of Erectile Dysfunction With Sildenafil

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Behavioral: Treatment Optimization Program (educational material)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects above age of majority for whom sildenafil is prescribed for the first time within the usual practice of medicine Exclusion Criteria: Male subjects who have used any ED medical treatments over the last month, with the exception of testosterone and/or herbal therapies Subjects who do not have the possibility of viewing the video either through a computer, VCR or a DVD

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Treatment Optimization Program (educational material)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of a sildenafil educational program versus usual care on subjects' satisfaction regarding their management of ED with sildenafil as assessed through the validated EDITS questionnnaire after 3 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the relationship between the administration of an educational program and the effectiveness of sildenafil; Evaluate the educational program as a tool to help physicians in their management of ED; Estimate the intracluster correlation coefficient |  |  |
Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms

Study Overview
=================
Brief Summary
-----------------
Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.

Conditions
-----------------
Neurofibromatosis 1, Diagnoses Disease, Post Traumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 or more, or parent of a children Patient with a neurofibromatosis type 1 or parent of a children with a neurofibromatosis 1 in de novo form Followed for a neurofibromatosis type 1 de novo at the dedicated consultation in the University Hospital of Brest, since april 2013 Agree to participate Exclusion Criteria: Patients aged of 18 years old or lower Refusal to participate

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 |
| --- | --- | --- |
| Study post traumatic stress disorder secondary to annoucement of diagnosis of neurofibromatosis type 1 in de novo form | Questionnaire Impact of Event Scale | Day 1 after diagnosis of neurofibromatosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study methods of annoucement and feeling of patients with a questionnaire | Questionnaires about: methods of announcement (who? when? how?) | Day 1 after diagnosis of neurofibromatosis | 
| Genetical analyze | Genetical analyze | Day 1 after diagnosis of neurofibromatosis | 
| Psychological or psychiatrical impact | Psychological or psychiatrical impact | Day 1 after diagnosis of neurofibromatosis | 
| Information about NF1 | Questions about look for information about disease | Day 1 after diagnosis of neurofibromatosis |
European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study

Study Overview
=================
Brief Summary
-----------------
The Fondazione per la Ricerca Ospedale di Bergamo (FROM) decided to propose and promote the completion of ERNEST registry: the aim of the project is to obtain up-to-date estimates of clinical outcome of these patients in primary and secondary Myelofibrosis that have been included in the 'original' ERNEST study. The last was conducted between 2012 and beginning of 2015 including 1292 patients with Myelofibrosis, but it was interrupted in 2015 because of bankruptcy of the previous sponsor.

Detailed Description
-----------------
Follow-up of patients already been registered in the ERNEST registry resulting alive and/or in active surveillance at November 2014 (Blood 2014 124:1849) will be updated retrospectively until December 2020. Data collection will be centralized at Fondazione per la Ricerca Ospedale di Bergamo (FROM), and performed by a web-based and Electronic Data Capture (EDC) system through ad hoc electronic case report forms (e-CRFs). The e-CRFs system will be pre-filled with pre-existing data collected from cases already entered in the registry. Information on therapies received and outcome events occurred (in term of death, evolution to acute leukemia, secondary cancer and cardiovascular complications) until December 2020 will be recorded by authorized participating investigators.

Official Title
-----------------
European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study

Conditions
-----------------
Myelofibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous registration in the ERNEST registry (2012 - 2014) diagnosis of MF performed between January 2001 and 2012 December Signed informed consent to continue participation in the registry Exclusion Criteria: None

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 |
| --- | --- | --- |
| Number of death | Overall Survival | 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with evolution to acute leukemia (AL) | Occurrence of AL from diagnosis to last observation | 18 years | 
| Number of patients with secondary tumor (ST) | Occurrence of ST from diagnosis to last observation | 18 years | 
| Number of patients with cardiovascular (CV) complications | Occurrence of events from diagnosis to last observation | 18 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
survival, acute leukemia, second cancer, cardiovascular complication, update, disease management
TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to evaluate the peri-operative, short-, and mid- outcomes of endovascular treatment of thoracoabdominal aneurysms with multibranched endografts via total transfemoral approach for visceral vessels cannulation using steerable sheaths

Official Title
-----------------
A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)

Conditions
-----------------
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic

Intervention / Treatment
-----------------
* Device: Steerable introducers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient adult ( ≥18 years) of either sex, patients who underwent a complex aortic procedure requiring a branched endograft via total transfemoral approach in the centers involved in the TORCH2 Registry Exclusion Criteria: patients who did not receive treatment via total transfemoral approach, patient with bleeding diathesis or coagulopathy, patients with active systemic or cutaneous infection or inflammation, patients who are pregnant or lactating, patient younger than 18 years of age. Absence of at least one imaging follow-up within the first post-operative year

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 |
| --- | --- |
| Steerable introducers<br> | Device: Steerable introducers<br>* endografts via total transfemoral approach for visceral vessels cannulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success | successful bridging stent graft deployment of all vessels, with aneurysm exclusion, without any signs of type I or type III endoleak, and with no evidence of stenosis/occlusion and mating stent dislocation/kinking at intraoperative completion angiography. | 30 days | 
| branch instability | freedom from any branch related complications and/or required reinterventions | 30 days | 
| clinical success | absence of death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoracoabdominal pathologies | 30 days |
Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.

Official Title
-----------------
Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines: Multi-center, Single Arm, Open, Extension Study

Conditions
-----------------
Crow's Feet Lines, Glabellar Lines

Intervention / Treatment
-----------------
* Drug: Clostridium Botulinum A Toxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of at least 18 to 75 years old moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator Subject who has completed phase 3 study for CFL.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clostridium Botulinum A Toxin<br>Clostridium Botulinum A Toxin | Drug: Clostridium Botulinum A Toxin<br>* Clostridium Botulinum A Toxin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Assessment of Satisfaction of Appearance | Subject Assessment of Satisfaction of Appearance | At 4 weeks |
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Official Title
-----------------
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes Patients who have been placed on diet and exercise therapy without achievement of glycemic control Outpatients Exclusion Criteria: Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant cardiovascular diseases Significant diabetic complications Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline for postprandial glucose at 12 weeks |  |  | 
| Change from baseline on fasting plasma glucose at 12 weeks |  |  | 
| Change from baseline on postprandial glucose AUC at 12 weeks |  |  | 
| Change from baseline in HOMA B at 12 weeks |  |  | 
| Change from baseline in HOMA IR at 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin, HbA1c
High-Risk HPV Infections in Women Aged 25 to 65

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.

Detailed Description
-----------------
Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a pilot study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 400 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect two sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. If new HPV infections associated with recent new partners are detected in these women, this pilot data will be used to develop a larger longitudinal study of the acquisition and natural history of HR HPV infections in older women. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.

Official Title
-----------------
High-Risk HPV Infections in Women Aged 25 to 65

Conditions
-----------------
Papillomavirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had sex with men Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website) Exclusion Criteria: Pregnant, breastfeeding, or planning a pregnancy in the next 6 months Hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| High-Risk HPV DNA |  | four months |