linjc16/ctgov huggingface dataset:
Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material. The secondary objective of the study is to evaluate if healthcare professionals know Dengvaxia product information, namely, age indication and contraindications.

Detailed Description
-----------------
The study is a cross-sectional Survey. Study data are collected through a questionnaire.

Official Title
-----------------
A Cross-sectional Survey to Evaluate Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

Conditions
-----------------
Dengue Virus Infection

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Healthcare professionals who are current or past prescribers of Dengvaxia Exclusion criteria: Healthcare professionals who have never prescribed Dengvaxia Healthcare professionals who may have a conflict of interest with the survey (i.e. Healthcare professionals employed by regulatory bodies, pharmaceutical industries) Healthcare professionales who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms The above information is not intended to contain all considerations relevant to participation in the survey.
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 |
| --- | --- |
| Prescribers of Dengvaxia<br>Healthcare professionals who are current or past prescribers of Dengvaxia | Other: No intervention<br>* Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare professionals' knowledge and understanding of key safety messages provided in risk minimization measures materials | Knowledge and understanding of key safety messages are assessed through a questionnaire | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare professionals' knowledge of Dengvaxia product information | Knowledge of Dengvaxia product information (age indication and contraindications) is assessed through a questionnaire | Day 0 |
Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide. It has been published in small trials or case series that the addition of acetate is associated with a rise in nitric oxide production of vascular smooth muscle cells, endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure drops, induction of proinflammatory cytokines and activation of complement and leukocytes have been described with acetate. Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis), Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects. Both dialysate additives (citrate and acetate) are commercially available and are used world wide in dialysis centers. The investigators hypothesize that substitution of acetate by citrate reduces the cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity and Augmentation index) and might improves quality of life in the participants. Furthermore the investigators speculate that citrate in the dialysis solution could reduce systemic inflammation in the participants of the study.

Official Title
-----------------
Effect of an Acetate-free Dialysis (Citrate Based) on Parameters of Central Hemodynamics, Dialysis Adequacy, Quality of Life and Immunological Parameters in Chronic Hemodialysis

Conditions
-----------------
End Stage Renal Disease (ESRD)

Intervention / Treatment
-----------------
* Other: Acetate by Citrate substitution and vice versa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: time since initiation of dialysis > 3 months age > 18 years dialysis 3x/week for > 4 hrs Exclusion Criteria: ongoing infection pregnancy lack of written and 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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetate<br> | Other: Acetate by Citrate substitution and vice versa<br>* substitution of acetate by citrate in dialysis fluid<br>|
| Experimental: Citrate<br> | Other: Acetate by Citrate substitution and vice versa<br>* substitution of acetate by citrate in dialysis fluid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Augmentation Index (AIx) | cross over design | 6 months (cross over after 3 months) |
Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID

Study Overview
=================
Brief Summary
-----------------
Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses. Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies. If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination. The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.

Official Title
-----------------
Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID

Conditions
-----------------
Identification of the Mother or Fetus Contamination by SARS Cov-2, Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father, The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes, Analysis Laboratories of the Poitiers CHU

Intervention / Treatment
-----------------
* Diagnostic Test: Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient Patient with late spontaneous abortion (≥15 weeks of gestation) Benefiting from a Social Security scheme Patient who consented to participate in the study Free subject, without tutorship, curatorship or subordination Exclusion Criteria: Persons not benefiting from a Social Security scheme or not benefiting from it through a third party. Concurrent participation in another clinical research study.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus|Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Presence of SARS-COV-2 virus in samples taken from mother and father. Circulating anti-SARS-COV-2 antibodies in the mother.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause. | Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus | 2 months |
Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Detailed Description
-----------------
Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Official Title
-----------------
A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.

Conditions
-----------------
Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Small-cell lung cancer. Patients who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy. Measurable or assessable disease. Life expectancy >2 months. Patients with a therapeutic risk level of <5 points (see section 6: Treatment flowchart). Age >18 years; Performance status (WHO) <2; One measurable target lesion in a non irradiated region; Prior radiotherapy authorized unless it targeted the only measurable lesion; Biological criteria: WBC >2000/mm3, PMN >1500/mm3, platelets >100 000/mm3, creatinemia <2 x ULN, bilirubinemia <ULN, ALT and AST <2.5 x ULN (< 5 N if liver metastases) normal ECG written informed consent. Exclusion Criteria: Non small-cell lung cancer. No objective response to platinum-based therapy Complete response lasting more than three months after the last course of first-line treatment. Symptomatic brain metastases. Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable disease manifestations.- Concurrent participation in another clinical trial. Therapeutic risk level of 6 points or more (see table) Uncontrolled clotting disorders; Uncontrolled severe infection; History of another malignancy, except for cervical carcinoma in situ or basocellular cancer that are considered cured; Psychological, familial, sociological or geographic circumstances preventing treatment follow-up as defined in the protocol; Patients deprived of their rights for administrative or legal reasons.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, Lung cancer, small-cell lung cancer
Comparison of Lidocaine and Remifentanil for the Effect on Responses to the Endotracheal Tube During Emergence From General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Target concentration infusion(TCI) of remifentanil (2.0ng/ml) suppresses the cough induced by endotracheal tube more effectively than intravenous administration of lidocaine (1.5mg/kg).

Official Title
-----------------
Comparison of Lidocaine and Remifentanil for the Effect on Responses to the Endotracheal Tube During Emergence From General Anesthesia

Conditions
-----------------
Thyroidectomy

Intervention / Treatment
-----------------
* Drug: remifentanil / lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females older than 20 years old Exclusion Criteria: Patients with acute or chronic respiratory disease, hypertension, gastro-esophageal reflux disease, having preoperative sedatives or mucolytics, and current smoker.

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

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: remifentanil / lidocaine|Remifentanil TCI group : target controlled infusion of 2.0ng/ml of remifentanil on end of surgery. Lidocaine IV group : Intravenous administration of 1.5mg/kg of lidocaine on end of surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of lidocaine and remifentanil for the effect on responses to the endotracheal tube during emergence from general anesthesia | The incidence and the grade of cough during emergence from general anensthesia between remifentanil TCI group and lidocaine IV administration group. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients scheduled to undergo thyroidectomy
Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

Study Overview
=================
Brief Summary
-----------------
The split-dose regimen (SpD) has demonstrated its superiority over the day-before regimen (DB) in determining a better colon cleansing and is considered the standard bowel preparation for colonoscopies by the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. However its application is still suboptimal due to concerns about patient acceptability, fluid aspiration due to residual gastric contents and challenging viability for early morning colonoscopies. Barriers precluding the prescription of SpD have been explored in few studies mainly in the setting of auditing of current practice, while corrective measure aiming at changing this practice have been prospectively tested in very few, small and selected, cohorts. The present study has the aim of surveying split-dose regimen adoption rate among several endoscopic centres before and after an improvement phase following a plan-do-study-act approach, in order to analyse and correct factors preventing its adoption. A multivariate analysis was planned in order to use collected data to infer factors favouring and limiting split-dose regimen adoption.

Official Title
-----------------
IMPlementing Split Regimen OVEr Single Dose

Conditions
-----------------
Colonoscopy: Bowel Preparation

Intervention / Treatment
-----------------
* Procedure: Colonoscopy
* Drug: Bowel cleansing regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing colonoscopy with full bowel cleansing Exclusion Criteria: Incapacity to give informed consent Partial colonoscopy

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 |
| --- | --- |
| Cycle1<br>Patients undergoing colonoscopy with full bowel cleansing before the improvement phase | Procedure: Colonoscopy<br> <br> Drug: Bowel cleansing regimen<br> <br> |
| Cycle2<br>Patients undergoing colonoscopy with full bowel cleansing after the improvement phase | Procedure: Colonoscopy<br> <br> Drug: Bowel cleansing regimen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants adopting a split-dose regimen in Cycle1 |  | 6 months | 
| Number of participants adopting a split-dose regimen in Cycle2 |  | 3 months | 
| Change from Cycle1 in the proportion of patients adopting a split-dose regimen during Cycle2 after an improvement phase |  | 9 months (Cycle1 = 6 months + Cycle2 = 3 months, separated by a 21-month improvement phase) |
Usefulness of Non TNF Usage in RA Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: Sarilumab treatment for 12 months Tocilizmab treatment for 12 months Abatacept treatment for 12 months

Official Title
-----------------
Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients

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

Intervention / Treatment
-----------------
* Drug: Drug: Salirumab
* Drug: Drug: Tocilizmab
* Drug: Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ・RA patients Exclusion Criteria: Not RA patients RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| Active Comparator: SAR, usually subucutaneous injection every 2 weeks<br> | Drug: Drug: Salirumab<br>* To examine the effects of salirumab in RA patients<br>Drug: Drug: Tocilizmab<br>* To examine the effects of tocilizmab in RA patients<br>Drug: Drug: Abatacept<br>* To examine the effects of abatacept in RA patients<br>|
| Active Comparator: TCZ, usually subucutaneous injection every 2 weeks<br> | Drug: Drug: Salirumab<br>* To examine the effects of salirumab in RA patients<br>Drug: Drug: Tocilizmab<br>* To examine the effects of tocilizmab in RA patients<br>Drug: Drug: Abatacept<br>* To examine the effects of abatacept in RA patients<br>|
| Active Comparator: ABT, usually subucutaneous injection every week<br> | Drug: Drug: Salirumab<br>* To examine the effects of salirumab in RA patients<br>Drug: Drug: Tocilizmab<br>* To examine the effects of tocilizmab in RA patients<br>Drug: Drug: Abatacept<br>* To examine the effects of abatacept in RA patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Values of DAS28-CRP | Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30). | Baseline and 1 year | 
| Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30). |  | at 1 year |
In Vitro Fertilization (IVF) and Acupuncture for Infertility

Study Overview
=================
Brief Summary
-----------------
The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.

Official Title
-----------------
IVF and Acupuncture for Infertility: A Randomized Controlled Trail

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: acupuncture
* Procedure: IVF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females between 21 and 42 years old primary or secondary infertility no more than 2 previously failed IVF cycles undergoing IVF FSH < 11 Exclusion Criteria: FSH > 11 using an egg donor using PGD using heparin or lovanox protocols estradiol level less than 20 or over 80 taking herbal therapy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 42 Years

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

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

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 |
| --- | --- |
| Active Comparator: 1<br>IVF | Procedure: IVF<br>* one 4 week IVF cycle<br>|
| Other: II<br>treatment | Procedure: acupuncture<br>* 16 treatments over 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy |  | week 10 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine blood flow |  | final measurement in week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, IVF, acupuncture
Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
Our aim was to diagnose and initiate early treatment for postpartum depression by detecting the changes of melatonin levels in c-sections with different antesthesia modalities.

Official Title
-----------------
The Effect of the Anesthesia Modality Used in Women Giving Birth Under Caesarian Section on Postpartum Depression and/or Postoperative Melatonin Levels

Conditions
-----------------
Postpartum Depression, Melatonin

Intervention / Treatment
-----------------
* Behavioral: postpartum depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women c-section (using general or regional anesthesia) aged between 18-45 years Exclusion Criteria: age under 18 or above 45, history of smoking, a diagnosis with mental retardation, psychiatric patients, use of antipsychotics or antidepressants, patients with sleeping disorders, hormone replacement theraphy patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| general anesthesia<br>c-section with general anesthesia | Behavioral: postpartum depression<br>* melatonin levels in c-sections with different anesthesia modalities.<br>|
| spinal anesthesia<br>c-section with spinal anesthesia | Behavioral: postpartum depression<br>* melatonin levels in c-sections with different anesthesia modalities.<br>|
| epidural anesthesia<br>c-section with epidural anesthesia | Behavioral: postpartum depression<br>* melatonin levels in c-sections with different anesthesia modalities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| edinburgh depression scale | below 12 is associated with depression | 5 months |