linjc16/ctgov huggingface dataset:
Parallel Versus Perpendicular Technique for Genicular Radiofrequency

Study Overview
=================
Brief Summary
-----------------
Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques.

Official Title
-----------------
Parallel Versus Perpendicular Technique for Genicular Radiofrequency Ablation

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Perpendicular Group
* Procedure: Parallel Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Intra-articular injections in the knee during the 3 months prior to procedure Chronic pain syndrome Lumbar radicular pain Patients who are unwilling or mentally incapable to complete the study questionnaires.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perpendicular Group<br>Perpendicular genicular radiofrequency application | Procedure: Perpendicular Group<br>* Radiofrequency ablation was applied to the perpendicular group by placing the tip of electrode perpendicularly to contact the genicular nerves.<br>|
| Active Comparator: Parallel Group<br>Parallel genicular radiofrequency application | Procedure: Parallel Group<br>* Radiofrequency ablation was applied to the parallel group by placing the electrode lay parallel to contact the genicular nerves.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) | The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (0-10).The lower the score, the least pain the patient experiences. | 6 months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | WOMAC is a 24-item scale under the headings of pain, stiffness and functional activity. Patients rate the amount of strain, pain felt, and joint stiffness during daily activities between 0 and 4 (0 is the best, 4 is the worst), and the total score is between 0 and 96. | 6 months after intervention. |
Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning

Study Overview
=================
Brief Summary
-----------------
Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.

Official Title
-----------------
Intubation Prediction in Sars-CoV-2 Patients Treated With Awake Prone Positioning

Conditions
-----------------
Acute Hypoxemic Respiratory Failure, SARS-CoV-2 Virus

Intervention / Treatment
-----------------
* Procedure: Awake prone positioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sars-CoV-2 pneumonia ICU stay Severe hypoxemia but non intubated Exclusion Criteria: Intubated before admission Denied consent for data analysis Do not intubate order at ICU admission

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 |
| --- |
|Procedure: Awake prone positioning|Awake prone position as long as possible according to the patients' tolerance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate |  | Once between ICU admission and extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolo-arterial gradient change |  | Within 6 hours before and 6 hours after each pronation | 
| Blood gas analysis |  | Within 6 hours before and 6 hours after each pronation | 
| Respiratory pattern |  | Within 6 hours before and 6 hours after each pronation | 
| Mortality |  | Up to 28 days from ICU admission |
Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the alternative pathway of the complement system. Triggering can cause an uncontrolled complement activation with endothelial damage and thrombotic micro-angiopathy, especially in the kidneys. This can result in endstage renal failure. Complement activation during hemodialysis has been described as a result of contact between blood and the dialysis membrane. Our hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger complement activation during hemodialysis than patients with another underlying kidney disease. This could be a reason to treat patients with endstage renal failure due to atypical hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.

Official Title
-----------------
Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease.

Conditions
-----------------
Atypical Hemolytic Uraemic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases: endstage renal failure due to atypical hemolytic uraemic syndrome treated with hemodialysis. controls: endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis.

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 |
| --- | --- |
| cases<br>patients with endstage renal failure due to atypical uraemic syndrome treated with hemodialysis. | |
| controls<br>patiënts with endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C3a-des-Arg measuring (as a marker of activation). |  | at time 0, at 15 minutes, at 60 minutes and at 180 minutes | 
| white blood cell count |  | before and after 15 minutes of hemodialysis |
ABTEST© Card Clinical Perfomance Study

Study Overview
=================
Brief Summary
-----------------
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

Detailed Description
-----------------
The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .

Official Title
-----------------
Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device

Conditions
-----------------
Transfusion Reaction

Intervention / Treatment
-----------------
* Diagnostic Test: ABTEST card


Participation Criteria
=================
Eligibility Criteria
-----------------
66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not. 10 neonatal patients, background transfusion or Guthrie test.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: in situ used for near patient In vitro Medical device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre transfusion control<br>Pre control transfusion with the referent reagent and the in study reagent | Diagnostic Test: ABTEST card<br>* Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between two reagents | performance of pre transfusional controls with the referent reagent and the reagent in study | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reagent Kits, Diagnostic
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study

Study Overview
=================
Brief Summary
-----------------
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

Detailed Description
-----------------
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.

Official Title
-----------------
Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto

Conditions
-----------------
Peripheral Arterial Disease, Arterio-venous Fistula, Arteriovenous Graft

Intervention / Treatment
-----------------
* Device: Serranator® Alto


Participation Criteria
=================
Eligibility Criteria
-----------------
Subject requires angioplasty Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PAD<br> | Device: Serranator® Alto<br>* Serranator® Alto PTA Serration Balloon Catheter<br>|
| AV Fistula<br> | Device: Serranator® Alto<br>* Serranator® Alto PTA Serration Balloon Catheter<br>|
| AV Graft<br> | Device: Serranator® Alto<br>* Serranator® Alto PTA Serration Balloon Catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of <50% by visual assessment at the intended target site after using the Serranator® device. | The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of device related Major Adverse Events (MAE) until discharge | Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular) | Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first |
Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

Study Overview
=================
Brief Summary
-----------------
This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.

Official Title
-----------------
Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

Conditions
-----------------
Sedation, Endoscopy

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of midazolam-induced paradoxical response Exclusion Criteria: Failed to obtain informed consent Pregnant or breast feeding women A severe cardiopulmonary or vascular disease with symptoms Cognitive or mental impairment

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol alone<br>Participants who receive propofol alone during sedative endoscopy. | Drug: Propofol<br>* Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.<br>|
| Active Comparator: Midazolam with propofol<br>Participants who receive midazolam + propofol during sedative endoscopy. | Drug: Propofol<br>* Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.<br>Drug: Midazolam<br>* midazolam with propofol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of paradoxical response | The proportion of participants who show paradoxical response during endoscopy | At the end of endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Midazolam, Propofol, Sedation
Oocyte Vitrification Aided With Cytochalasin B

Study Overview
=================
Brief Summary
-----------------
Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte vitrification.

Official Title
-----------------
Cytochalasin B for Oocyte Vitrification

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

Intervention / Treatment
-----------------
* Other: Cytochalasin B supplemented vitrification medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for oocyte vitrification Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cytochalasin B supplemented vitrification medium<br> | Other: Cytochalasin B supplemented vitrification medium<br>* Vitrification of human oocyte in medium supplemented with Cytochalasin B<br>|
| No Intervention: Vitrification medium with no supplementation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival after thawing |  | 6 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate |  | 6 days of culture | 
| Rates of blastocyst formation and quality | Number of formed blastocyst and blastocyst with high-quality per fertilized oocytes | 6 days of culture | 
| embryo utilisation rate |  | 6 days of culture | 
| clinical pregnancy rate |  | three months | 
| ongoing pregnancy rate |  | 12 months |
Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation

Study Overview
=================
Brief Summary
-----------------
To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.

Official Title
-----------------
Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: lasofoxifene
* Drug: Placebo
* Drug: Lasofoxifene
* Drug: Lasofoxifene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal Asian women with osteoporosis defined by low BMD Exclusion Criteria: Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasofoxifene Dose 1<br>0.05 mg | Drug: lasofoxifene<br>* 0.05 mg tablets<br>|
| Experimental: Lasofoxifene Dose 2<br>0.25 mg | Drug: Lasofoxifene<br>* 0.25 mg tablets<br>|
| Experimental: Lasofoxifene Dose 3<br>0.5 mg | Drug: Lasofoxifene<br>* 0.5 mg tablets<br>|
| Placebo Comparator: Placebo<br>0 mg | Drug: Placebo<br>* 0 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment | Percent change from baseline in lumbar spine BMD at Month 12 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year | Percent change from baseline in lumbar spine BMD at Month 6, percent change in baseline in hip BMD at Month 6 and Month 12, percent change from baseline in bone metabolism markers at Month 6 and Month 12, percent change from baseline in serum lipids, total cholesterol, high-density lipoprotein cholesterol, triglycerides, lipoprotein (a), apoliporpotein-A1, apolipoprotein-B at Month 6 and Month 12 and incidence of new vertebral fractures at Month 12 | Month 6 and Month 12 |
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.

Conditions
-----------------
Chronic Kidney Disease, Tuberculosis

Intervention / Treatment
-----------------
* Drug: Rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: from 18yrs to 80yrs , man and women the patient who are taking rifampicine over 2weeks the patient sign on the concent form Exclusion Criteria: the patient have experience to take medication that have an effect on renal function the patient have hypersensitivity to colchicine At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40 beats/min or > 90 beats/min uncontrolled hypertension serum albumin < 3.5, > 5 g/dL acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine. the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid the patient who had taken part in the other study within 3months the patient who had gotten blood transfusion pregnant, breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifampicin<br>experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin | Drug: Rifampicin<br>* single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration<br>* Other names: Rifampin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration |  | the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration |