linjc16/ctgov huggingface dataset:
Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.

Official Title
-----------------
Efficacy and Tolerability of Fluvastatin in Adults With Dislipidemia With History of Muscle Problems Due to Other Previous Statin Intake

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyslipidemia History of Myalgia Exclusion Criteria: Previous treatment with fluvastatin Age < 18 years Other protocol-defined inclusion and exclusion criteria may apply.

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
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low density lipoprotein cholesterol after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation |  |  | 
| Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks |  |  | 
| Number of patients who reach target LDL after 12 weeks |  |  | 
| Change from baseline in marker of inflammation after 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyslipidemia, adults, fluvastatin
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.

Official Title
-----------------
A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis

Conditions
-----------------
Aspergillosis

Intervention / Treatment
-----------------
* Drug: Micafungin
* Drug: Liposomal Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy Exclusion Criteria Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion Has life expectancy of less than five days
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Micafungin<br>* IV<br>* Other names: FK463;Drug: Liposomal Amphotericin B<br>* IV<br>* Other names: AmBisome;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment response defined as complete or partial response |  | Day 28, end of combined therapy and Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response |  | Day 28, end of combined therapy and Day 84 | 
| Radiological Response |  | Day 28, end of combined therapy and Day 84 | 
| Mycological Response |  | Day 28, end of combined therapy and Day 84 | 
| Survival at Day 84 |  | Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspergillus, Aspergillosis, Anti-Fungal, AmBisome, Micafungin
14 g vs. 16 g in Breast Biopsy

Study Overview
=================
Brief Summary
-----------------
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies

Official Title
-----------------
Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy

Conditions
-----------------
Breast Biopsy

Intervention / Treatment
-----------------
* Diagnostic Test: needle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 18 years Informed consent available Palpable and non-palpable breast findings Tumor size 5-20 mm Findings of sonographic BI-RADS® classification 2-5. Guideline-oriented indication for bioptic clarification Exclusion Criteria: No reliable sonographic demarcation of the finding Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of 14 vs 16 gauge needles
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 14 gauge needle biopsy<br>breast biopsy will be performed with 14 gauge needle | Diagnostic Test: needle biopsy<br>* breast biopsy using different needle gauges<br>|
| Active Comparator: 16 gauge needle biopsy<br>breast biopsy will be performed with 16 gauge needle | Diagnostic Test: needle biopsy<br>* breast biopsy using different needle gauges<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy Additive diagnostic accuracy to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy | 1 year | 
| Diagnostic quality | Diagnostic quality of specimen to achieve an accurate histological diagnosis Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy Additive diagnostic quality to achieve a high (>=99%) diagnostic yield, with 1-5 passes of core needle biopsy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related to the biopsy procedure | Subjective pain perception measured visual analog scale | 1 year | 
| Duration time of the biopsy procedure | Duration time of the biopsy procedure | 1 year |
Visionaire: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system. It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee. It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.

Official Title
-----------------
Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: Visionaire system (Knee MRI)
* Other: No Knee MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA Exclusion Criteria: prior TKA ipsilateral upper tibial or distal femoral osteotomy ipsilateral total hip arthroplasty patient with significant >15o varus or valgus morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-aided TKA<br>The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient. | Other: Visionaire system (Knee MRI)<br> <br> * Other names: Visionaire;|
| Other: Conventional TKA<br>A conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA. | Other: No Knee MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degrees off normal AP and lateral alignment |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total knee arthroplasty (TKA), Computer aided systems
Acceptability Dermacyd Wipes - Lactoserum - Hygiene

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes

Official Title
-----------------
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up of Dermacyd Wipes

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: lactoserum


Participation Criteria
=================
Eligibility Criteria
-----------------
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: Inclusion Criteria: Integral skin in the tested region Exclusion Criteria: Pregnancy or breastfeeding women; Use of antiinflammatory or immunosuppression drugs; Topical medication use at the region to be treated; Cutaneous disease or active gynaecological disease which may interfer in study results; Personal history of allergic disease at the area to be treated; Allergic or atopic history.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and their association with the treatment. |  |  |
Allis Clamp Versus Single-tooth Tenaculum

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.

Official Title
-----------------
Cervical Bleeding With Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-tooth Tenaculum

Conditions
-----------------
IUD

Intervention / Treatment
-----------------
* Procedure: Allis clamp
* Procedure: Single-tooth tenaculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obtaining IUD Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IUD placement with allis clamp<br> | Procedure: Allis clamp<br>* Physicians utilized an Allis clam for cervical stabilization during IUD placement.<br>|
| Active Comparator: IUD placement with single tooth tenaculum<br> | Procedure: Single-tooth tenaculum<br>* Physicians utilized a single-tooth tenaculum clam for cervical stabilization during IUD placement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who experienced bleeding after IUD placement | Number of patients who experienced bleeding after IUD placement with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD insertion success rate | The percentage of participants who successfully had an IUD placed with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion | 
| Number of interventions required for cervical clamp site bleeding hemostasis | Number of interventions required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion | 
| Time to hemostasis | The time in seconds required to achieve hemostasis after IUD placement with an Allis clamp or single-tooth tenaculum. | At the time of IUD insertion | 
| Participant reported pain | Pain reported by the participant (0-10 where a higher number indicates greater pain) at the time of IUD placement with n Allis clamp or single-tooth tenaculum. | At the time of IUD insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical stabilization
The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).

Detailed Description
-----------------
Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.

Official Title
-----------------
The Haemodynamic Effects of Mechanical Standard and Active External Chest Compression-decompression During Out-of-hospital Cardiopulmonary Resuscitation

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: LUCAS2 AD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in: Patients 18 years or older Exclusion Criteria: Traumatic cardiac arrest Age believed to be less than 18 years Known pregnancy Victim not to be resuscitated (DNR orders) Internals in prison Included once in the study already To Small/Large patients Sustained ROSC occurring before the LUCAS™ 2 or LUCAS™ 2-AD can be applied to the patient, such that further CPR is not needed

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LUCAS 2 AD<br>LUCAS 2 AD will be used for CPR | Device: LUCAS2 AD<br>* LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.<br>|
| Other: LUCAS2<br>LUCAS2 will be used for CPR | Device: LUCAS2 AD<br>* LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics measured as EtCO2 |  | During 30 minutes of CPR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra arterial blood pressures, |  | During 30 minutes of CPR | 
| Oximetry, |  | During 30 minutes of CPR | 
| ROSC (Return of spontaneous circulation) |  | During CPR | 
| safety |  | During 30 minutes of CPR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mechanical CPR, Hemodynamics
Simulating Laparoscopy With an Eye Patch

Study Overview
=================
Brief Summary
-----------------
Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.

Detailed Description
-----------------
Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch. Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks. They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method. All participants will complete the tasks on both the computerized lap simulator and the box trainer.

Official Title
-----------------
Laparoscopic Skill Acquisition; Can the Loss of Depth Perception Associated With Laparoscopic Surgery be Adequately Simulated by an Eye Patch?

Conditions
-----------------
Laparoscopic Training

Intervention / Treatment
-----------------
* Device: Computerized Laparoscopic Trainer
* Device: Box trainer with eye patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic Novices 20-40 years All genders Exclusion Criteria: Previous laparoscopic surgical experience

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laparoscopic Novices<br>Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch. Time to completion is recorded. | Device: Computerized Laparoscopic Trainer<br>* Gold standard laparoscopic trainer using simulated computerized equipment.<br>Device: Box trainer with eye patch<br>* Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to completion of laparoscopic tasks. |  | 5 minutes |