linjc16/ctgov huggingface dataset:
Efficacy and Safety of Duloxetine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Official Title
-----------------
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence

Conditions
-----------------
Urinary Stress Incontinence

Intervention / Treatment
-----------------
* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female out patients. Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry. Exclusion Criteria: Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study. Suffer from severe constipation.

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

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

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

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: Duloxetine|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint. |  |  | 
| Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage |  |  | 
| Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores |  |  | 
| Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4) |  |  | 
| Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events |  |  |
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Study Overview
=================
Brief Summary
-----------------
st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (> 5 mm). nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI. rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.

Official Title
-----------------
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

Conditions
-----------------
Parotid Tumor

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Patient candidate for first line surgery for a parotid tumor Parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ENT surgeon and the imaging data Affiliate or beneficiary of a social security scheme Written consent to participate in the study Exclusion Criteria: Personal history of parotid homolateral surgery Absolute or relative contraindication to MRI Known hypersensitivity to gadolinic contrast media Pre or post operative period of a liver transplant Patient benefiting from a legal protection measure Pregnant or lactating woman Patient who has already benefited from a preoperative MRI to characterize a complete, well conducted and interpretable parotid lesion

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: MRI|All patients included will benefit from the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor: New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection; Gold standard: Intraoperative examination.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences. | measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences. | day 0 | 
| assessment by the surgeon during the excision surgery of the parotid lesion | assessment by the surgeon during the excision surgery of the parotid lesion | day 0 |
A Study of Flexible Ureteroscopy Proficiency After Training on the Uromentor Simulator

Study Overview
=================
Brief Summary
-----------------
The development of virtual reality (VR) simulators is changing surgical endoscopic education. The translation of VR skills into clinical endoscopic proficiency has been shown by M.PEARLE. The improvement in performing endoscopic tasks after VR training was evaluated on a cadaver. Our goal is to evaluate the performance of novice endoscopists at the operating room by a randomized controlled study comparing subjects randomized to train on a the UroMentor simulator to those without VR training.

Conditions
-----------------
Endoscopic Skills

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: novice urologists without endo-urological experience Exclusion Criteria: none
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 |
| --- | --- |
| 1<br>uromentor training | |
| 2<br>non uromentor training | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus

Study Overview
=================
Brief Summary
-----------------
Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections. This study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies. Research question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?

Conditions
-----------------
HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Intervention / Treatment
-----------------
* Dietary Supplement: probiotic drinkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with a new LSIL diagnosis an HPV positivity on PAP smear Exclusion Criteria: women over 65 immunocompromised patients (because of disease or drugs)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| No Intervention: common care<br>HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear | |
| Experimental: probiotic drinkers<br>HPV+, LSIL patients who will drink the study drink for 6 months | Dietary Supplement: probiotic drinkers<br>* HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.proportion of HPV positives in both arms |  | 6months | 
| 2. proportion of regression of LSIL lesion in both arms |  | 6 months |
Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube

Study Overview
=================
Brief Summary
-----------------
One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT. The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.

Official Title
-----------------
Comparison of Insertion Time Over Fiberoptic Bronchoscope Between Double Lumen Tube and Single Lumen Tube

Conditions
-----------------
Intubation;Difficult

Intervention / Treatment
-----------------
* Device: single lumen tube and bronchial blocker
* Device: double lumen tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2 Exclusion Criteria: abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI > 35

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single lumen tube<br>fiberoptic intubation with single lumen tube with bronchial blocker. | Device: single lumen tube and bronchial blocker<br>* fiberoptic intubation with single lumen tube and bronchial blocker<br>|
| Experimental: double lumen tube<br>fiberoptic intubation with double lumen tube. | Device: double lumen tube<br>* fiberoptic intubation with double umen tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion time | time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus | at anesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiberoptic intubation, double lumen tube
A Study to Examine Levels of Sedation During Outpatient Colonoscopies

Study Overview
=================
Brief Summary
-----------------
Examine levels of sedation required for patients to comfortably undergo colonoscopy using propofol and if adjunct monitoring equipment promotes patient safety.

Detailed Description
-----------------
Propofol for sedation during outpatient endoscopy has become a popular technique in place of midazolam and opioid sedation. It has been associated with improved patient satisfaction and a faster recovery with less nausea and vomiting. However, there are a number of potential adverse effects associated with propofol. It has no analgesic effects; therefore, when used for moderate sedation procedures it frequently has to provide deeper levels of sedation to allow a painful procedure to be performed. Some patients are sedated to the level of general anesthesia and may develop respiratory depression or airway obstruction requiring immediate airway support. We examined the level of sedation required for patients to comfortably undergo routine colonoscopy using propofol and what monitoring system would best predict the patients who might need an airway intervention.

Official Title
-----------------
A Prospective, Blinded Study Examining Sedation Levels During Outpatient Colonoscopies

Conditions
-----------------
Outpatient Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years of age ASA classification of I, II, or III Exclusion Criteria: Anesthesiologist plans to use a combination of medications other than propofol for sedation. ASA classification IV or higher Lesions on forehead or earlobes

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 |
| --- | --- |
| Blinded Group<br>SEDline output is unknown to anesthesiologist. | |
| Unblinded Group<br>SEDline output is known to anesthesiologist. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine possible relationships (correlations) between sedation using the SEDLine monitors and level of sedation using the Ramsay Sedation Scale and examine the number and type of airway interventions and clinical signs performed during the procedure. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Sedation levels
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS

Study Overview
=================
Brief Summary
-----------------
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Official Title
-----------------
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, Angioplasty

Intervention / Treatment
-----------------
* Drug: additional rosuvastatin loading
* Drug: placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 year old diagnosed as acute coronary syndrome Plan to PCI Exclusion Criteria: STEMI patient emergency PCI(<2h) for NSTE-ACS History of liver disease and myopathy (ALT/AST>3 x upper limit of normal,CK>5 x upper limit of normal) TG>500mg/dl,CCr<30ml/min inflammatory disease allergic to rosuvastatin nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rosuvastatin,one month,lipid lowering<br>additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI | Drug: additional rosuvastatin loading<br>* additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI<br>|
| Placebo Comparator: sugar pill, one month<br>sugar pill is given 18-24hr and 4-6hr before PCI as control | Drug: placebo control<br>* sugar pill is given 18-24hr and 4-6hr before PCI as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-procedural myocardial damage |  | 48 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE |  | 30 days after PCI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosuvastatin, angioplasty, acute coronary syndrome
Cabergoline as a Preventive Treatment for Chronic Migraine

Study Overview
=================
Brief Summary
-----------------
Headache disorders constitute a major global disease burden, and migraine - with a one-year prevalence of 15 % - is the sixth most disabling condition. Though a common disease, the pathogenesis is still unclear. Thus, the treatments have different mechanisms of action and preventive treatments are only effective in approximately 50% of chronic migraine patients. Recent evidence from mice models and a study of prolactine-associated headaches have indicated that dopamine agonists such as cabergoline might be used as a treatment of migraine. The aim of this study is to test the hypothesis that the dopamine agonist cabergoline can be used as a treatment of chronic migraine. A randomized controlled trial of 24 patients with chronic migraine will be conducted, comparing cabergoline to placebo as an add-on medication to the patients' migraine treatment over a 12 weeks period. The primary outcome is change in migraine frequency, but also headache-related hospital contacts, and quality of life as well as prolactin levels and biomarkers of the pituitary-gonadal-axis. The results of the study will help understand the pathogenesis of migraine and might also introduce a more effective and affordable preventive migraine treatment.

Official Title
-----------------
Cabergoline as a Preventive Treatment for Chronic Migraine: an Investigator-Initiated, Randomized Clinical Trial

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Cabergoline 0.5 MG
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine and more than 6 days with headache every months Exclusion Criteria: Cardiac valve disease Hypertension Psychiatric disease Treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides and itraconazole pregnant or breastfeeding

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, placebo-controlled parallel study with a 12 weeks duration.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabergoline<br> | Drug: Cabergoline 0.5 MG<br>* Cabergoline 0.5 mg once a week in 12 weeks<br>|
| Placebo Comparator: Control<br> | Other: Placebo<br>* Placebo once a week in 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in days with headache in patients with chronic migraine | Based on a headache diary | 12 weeks |
Using National University Cancer Institute of Singapore (NCIS) Registry to Measure Time Trends in Quality of Care for Breast Cancer Patients in a National Cancer Centre

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesise that the research data will enable them to elucidate local clinical practices with regard to breast cancer care and enable them to extrpolate the data to improved local clinical care for their patients through self-regulation and audit.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 21 years old Exclusion Criteria: No patient involved

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of care at NCIS using indicators |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The trends and variations in quality of care indices over a period of years |  | 2 years |
Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the performance of contact lens maintenance systems when used with silicone hydrogel contact lenses during daily wear over a period of 1 month.

Conditions
-----------------
Myopia, Hyperopia

Intervention / Treatment
-----------------
* Device: Silicone hydrogel contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses. Is an experienced soft contact lens wearer for at least 1 month. Has no clinically significant anterior eye findings. Has no other active ocular disease. Exclusion Criteria: Requires concurrent ocular medication. Eye surgery or injury within 12 weeks prior to enrolment. Has any systemic disease or ocular abnormality that might interfere with contact lens wear Has any pre-existing ocular irritation that would preclude contact lens fitting. PMMA lens wear previous 6 months. EW or CW in previous 1 month. Hydrogen peroxide users Latex sensitivity

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Silicone hydrogel contact lens|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |