linjc16/ctgov huggingface dataset:
Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research

Study Overview
=================
Brief Summary
-----------------
This single-center study will identify the representations and opinions of Advanced Practise Nurses (IPA) in nephrology in the Auvergne Rhône Alpes (AURA) region about clinical research. The study will consist of individual semi-directive interviews with Advanced Practise Nurses (IPA).

Official Title
-----------------
Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research

Conditions
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Caregivers

Intervention / Treatment
-----------------
* Other: Interviews
* Other: Qualitative analysis


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Hold a state diploma in advanced practice nursing Have been working at the health facilities for at least 3 months Working in France Exclusion Criteria: - Refusal to participate in the study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Nephrology Practice Nurses<br>Advanced Nephrology Practice Nurses in France will be included. | Other: Interviews<br>* Individual semi-structured interviews<br>Other: Qualitative analysis<br>* Thematic analysis of the content of responses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speeches collected during semi-structured interviews | To explore the beliefs and attitudes of IPA in nephrology about clinical research. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the responses to the follow-up questions | To identify barriers and facilitators of the involvement of this profession in clinical research. | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced practice nurse, Clinical research
Main Postoperative Complications After COVID-19

Study Overview
=================
Brief Summary
-----------------
To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.

Official Title
-----------------
Main Postoperative Complications After SARS-CoV-2 Infection: A Prospective Cohort Study

Conditions
-----------------
Intestines Cancer, Pulmonary Cancer, Liver Cancer, Trauma, Fractures, Bone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 years; Patients undergoing any type of elective or confine surgery in operating room; Informed consent. Exclusion Criteria: Surgery under local anesthesia (without participation of anesthetist) Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc Patients who cannot determine whether they have had SARS CoV-2 infection before surgery Participating in conflicting clinical study

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 |
| --- | --- | --- |
| All-cause mortality at 30 days after operation | All-cause mortality at 30 days after operation | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main pulmonary complications at 30 days after operation | a composite of postoperative pneumonia, acute respiratory distress syndrome (ARDS) and unexpected ventilation | 30 days after surgery | 
| Major Adverse Cardiovascular Events (MACE) | a composite of myocardial infarction, new-onset heart failure or cardiogenic shock, deep vein thrombosis (DVT), pulmonary embolism (PE), and cerebrovascular accident (CVA) | 30 days after surgery |
BIOSTREAM.HF HeartInsight

Study Overview
=================
Brief Summary
-----------------
The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.

Official Title
-----------------
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: HeartInsight activation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient willing and able to give consent Participation in BIO|STREAM.HF HeartInsight-capable CRT-D device implanted or planned to be implanted Symptomatic heart failure NYHA class II or III within 45 days prior to enrollment HeartInsight score available or planned use of HeartInsight History of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure Patient is willing and able to utilize BIOTRONIK Home Monitoring via CardioMessenger and has sufficient mobile network coverage Exclusion Criteria: Patient with permanent atrial fibrillation or 100% atrial pacing Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated History of patient incompliance

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 |
| --- |
|Other: HeartInsight activation|HeartInsight is activated at enrollment. The attending physicians are free on how to integrate HeartInsight in the patient care. Any treatment is based on routine care according to guidleines. Only documentation occurs on how the physicians use HeartInsight and actions taken in response to HeartInsight alerts|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of WHF hospitalization after HeartInsight activation | Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active | through study completion, an average of 1.5 years |
Observational Monocentric Study on Biliary Tract Cancer (BABEL)

Study Overview
=================
Brief Summary
-----------------
BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.

Detailed Description
-----------------
BABEL is an observational, single-center, prospective study with an historical cohort. Study population is represented by patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study involves an historical cohort and a prospective cohort. Primary aim of the study is to associate BTC patients' overall survival with IDH1/2 mutations, in order to confirm the prognostic role of these genes both metastatic and resectable disease setting. The secondary aims are to correlate FGFR mutations and overall survival of BTC patients and to find new clinical and molecular characteristics linked with survival and response to treatment.

Official Title
-----------------
The Prognostic and Predictive Role of Clinical, Biochemical, Pathological and Molecular Characteristics of Patients With Biliary Tract Cancer: an Observational Monocentric Study. (BABEL)

Conditions
-----------------
Biliary Tract Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biliary tract cancer; Patients with radiological evident disease; Patients >18 anni; Written informed consent; Patients with at least one oncological visit. Exclusion Criteria: Patients without available clinical data; Patients without histological diagnosis of BTC; Patients without written informed consent.

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 | OS is defined as the time between patient's date of diagnosis and date of death from any cause of the patient. For patients with no observed event, the follow-up time will be ended to the same date. | The expected OS for BTC patients is 18 months |
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.

Official Title
-----------------
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Radiation: POHIM_EM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed endometrioid type endometrial cancer completion of hysterectomy and surgical staging pathologically confirmed FIGO stage III ECOG performance status 0 or 1 adjuvant chemotherapy was done or planned Exclusion Criteria: presence of distant metastasis previous history of pelvic radiotherapy severe and unstable medical condition previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: hypofractionated IMRT (2.5 Gy x 16 fractions)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POHIM_EM<br>adjuvant hypofractionated IMRT for endometrial cancer | Radiation: POHIM_EM<br>* hypofractionated intensity-modulated radiation therapy (2.5 Gy/fraction, 16 fractions)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year disease-free survival rate | disease-free survival rate after the time of surgery | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute toxicities | acute toxicities within 3 months according to CTCAE v5.0 | 3 months | 
| late toxicities | late toxicities according to CTCAE v5.0 | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation therapy, hypofractionation
Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Detailed Description
-----------------
Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.

Official Title
-----------------
Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: DKP21102_C
* Drug: DKP21102_B
* Drug: DKP21102_A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A man or woman over 19 years old. Patients with coronary heart disease or risk of coronary heart disease Exclusion Criteria: History of Unstable angina, myocardial infarction etc Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%) renal impairment (Creatinine clearance < 60 mL/min) etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: Control group<br>DKP21102_A, DKP21102_C | Drug: DKP21102_C<br>* Placebo<br>Drug: DKP21102_A<br>* Active Control<br>|
| Experimental: Treatment group<br>DKP21102_A, DKP21102_B | Drug: DKP21102_B<br>* Treatment<br>Drug: DKP21102_A<br>* Active Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change (%) of non-HDL-C from baseline | non-HDL-C | from baseline at 12weeks |
Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.

Detailed Description
-----------------
Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Official Title
-----------------
Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Behavioral: Sleep intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: During the first trimester of pregnancy Singleton pregnancies Exclusion Criteria: Women have pregnancy-related complications Women have diagnosed a psychiatric or sleep disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training. | Behavioral: Sleep intervention<br>* Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.<br>|
| No Intervention: Control<br>Women in the control group will receive standard obstetric care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep by actigraphy | Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist | Through study completion, an average of 16 weeks |
Mindfulness Intervention and Online Social Networking

Study Overview
=================
Brief Summary
-----------------
This study aims to examine (a) the effects of mindfulness-based intervention on wellbeing including psychological, social, and emotional wellbeing, depressive symptoms, and stress and (b) the extent to which demographics, OSN use, and mindfulness mediate these effects.

Official Title
-----------------
Mindfulness Intervention on Wellbeing During OSN

Conditions
-----------------
Mindfulness

Intervention / Treatment
-----------------
* Behavioral: Mindfulness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Exclusion Criteria: have not complete the application form

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: waitlist control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Intervention Group<br>Mindfulness training will be provided to the participant after randomization for dealing with social media use. | Behavioral: Mindfulness<br>* Mindfulness is paying attention in a particular way: on purpose, in the present moment, and non-judgmentally (Kabat-Zinn 1994, 4) and has five facets: awareness, nonjudgement, nonreactive, observe, and describe (Baer et al., 2006).<br>|
| No Intervention: Waitlist Control Group<br>No mindfulness training will be provided to the participants. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Media Engagement | The Social Media Engagement Scale | 8 weeks | 
| Well-being | Well-being Scale | 8 weeks | 
| Emotion | Difficulties in Emotion Regulation Scale | 8 weeks | 
| Depression | Depression and Anxiety Stress Scales | 8 weeks |
Opinions of Healthcare Providers About a European Neuromodulation Register

Study Overview
=================
Brief Summary
-----------------
The goal of this online survey is to gain further insights in the needs and burden for a European registry for neuromodulation, according to healthcare providers.

Official Title
-----------------
Opinions of Healthcare Providers About a European Neuromodulation Register: an Online Survey

Conditions
-----------------
Registry, Neuromodulation, Survey

Intervention / Treatment
-----------------
* Behavioral: Filling in an online survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses). Exclusion Criteria: Not involved in management of chronic pain through neuromodulation.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare professionals involved in neuromodulation<br> | Behavioral: Filling in an online survey<br>* Professionals are asked to complete questions regarding 1) the degree of current participation in a registry, 2) the need for a European registry, 3) the items that should be collected and 4) access to the European registry.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare providers their current degree of participation in a registry for neuromodulation. | Degree of participation in a registry for neuromodulation (question). | Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023. | 
| Healthcare providers their need for a European registry. | Underlying reasons on why a European registry is needed, or not needed (question). | Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023. | 
| Items that should be included in a registry for neuromodulation, according to healthcare providers. | Items that should be collection within a registry, evaluated with a multiple choice question. | Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023. | 
| Access regulations to European registry for neuromodulation, according to healthcare providers. | Access regulations, evaluated with a multiple choice question. | Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023. |