linjc16/ctgov huggingface dataset:
Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension

Conditions
-----------------
Hypertension, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: DP-R212
* Drug: C1-R212
* Drug: C2-R212


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both man and woman who is over 19 years old Hypertension patient with hypercholesterolemia Exclusion Criteria: sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg A history of cardiovascular disease rhabdomyolysis, myopathy Hypertension or hypercholesterolemia due to secondary causes Uncontrolled diabetes Evidence of hepatic or renal disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DP-R212 group<br>DP-R212 + C1-R212 placebo + C2-R212 placebo | Drug: DP-R212<br>* DP-R212 + C1-R212 placebo + C2-R212 placebo<br>|
| Active Comparator: C1-R212 group<br>DP-R212 placebo + C1-R212 + C2-R212 placebo | Drug: C1-R212<br>* DP-R212 placebo + C1-R212 + C2-R212 placebo<br>|
| Active Comparator: C2-R212 group<br>DP-R212 placebo + C1-R212 placebo + C2-R212 | Drug: C2-R212<br>* DP-R212 placebo + C1-R212 placebo + C2-R212<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of LDL-Cholesterol |  | 0, 8 weeks | 
| Change of mean seated Systolic Blood Pressure |  | 0, 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R212
Slipping Rib Syndrome: A Clinical Entity to Consider in Chest Pain

Study Overview
=================
Brief Summary
-----------------
Slipping rib syndrome consists on false or floating ribs hypermobility, whose can force the ribs to come in contact with each other. The authors reported a fourteen case series presenting a slipping rib syndrome.

Detailed Description
-----------------
Slipping rib syndrome consists on false or floating ribs hypermobility, whose can force the ribs to come in contact with each other. The authors reported a fourteen case series presenting a slipping rib syndrome. Mean age 35.00 ± 10.66 years old; 64.29% men. The 10th rib level was the most predominant, affecting 64.29% of cases. Dynamic ultrasound was the gold standard diagnostic tool. Different conservative treatments were applied in most of cases.

Official Title
-----------------
Slipping Rib Syndrome: A Clinical Entity to Consider in Chest Pain

Conditions
-----------------
Slipping Rib Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Dynamic ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting costal pain around 9th, 10th, or 11th rib. Exclusion Criteria: Patients younger than 18 years old and older than 80 years old.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Dynamic ultrasound|Diagnosis was based on clinic suspicion and positive ultrasonography dynamic maneuvers by reproducing pain and slipping rib exam|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypermobility level | Level of costal rib where there is hypermobility | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sports | If the subject participates in some kind of sport activity | 1 minute | 
| Pain mechanism | Pain mechanism could be repetitive movement, trauma or pregnancy | 2 minutes | 
| Diagnosis delay | Time of delay in have a diagnosis (in years) | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Slipping rib syndrome, dynamic ultrasound
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.

Study Overview
=================
Brief Summary
-----------------
All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.

Official Title
-----------------
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.

Conditions
-----------------
Non Variceal Bleed

Intervention / Treatment
-----------------
* Biological: Fresh Frozen Plasma
* Biological: Platelets Concentrate
* Biological: Cryo Precitipitate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 All patient with Non Variceal bleed (INR>1.8 and platelets<50000) Hist logical or imaging proven liver cirrhosis. Exclusion Criteria: Variceal Bleed, Pregnancy., Patients on anticoagulation Patients who refused to participate in the study Post EVL ulcer bleed

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thromboelastography (TEG) level<br> | Biological: Fresh Frozen Plasma<br> <br> Biological: Platelets Concentrate<br> <br> Biological: Cryo Precitipitate<br> <br> |
| Active Comparator: Coagulation Profile<br> | Biological: Fresh Frozen Plasma<br> <br> Biological: Platelets Concentrate<br> <br> Biological: Cryo Precitipitate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of FFP (Fresh Frozen Plasma) transfusion in both groups |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bleed in both groups |  | 5 days | 
| Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups. |  | 42 days | 
| Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups. |  | 42 days | 
| Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups. |  | 42 days |
Multihole or Epidural Catheter for Local Anesthetic in the Wound

Study Overview
=================
Brief Summary
-----------------
Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined. This study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.

Official Title
-----------------
Multihole or Epidural Catheter for Local Anesthetic in the Wound

Conditions
-----------------
Postoperative Pain, Hip Arthroplasty

Intervention / Treatment
-----------------
* Other: 2 mBq radioactive technetium diluted in 20 mL saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operation with total hip arthroplasty Exclusion Criteria: allergies to drugs administered
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| epidural catheter<br>subfascial placement of a triple-orifice epidural catheter | Other: 2 mBq radioactive technetium diluted in 20 mL saline<br> <br> |
| multiholed catheter<br>subfascial placement of a multi-orifice 15 cm catheter | Other: 2 mBq radioactive technetium diluted in 20 mL saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound spread area of radioactive isotope |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total hip arthroplasty
The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is treated with statins in low doses only as high doses can lead to rhabdomyolysis and are therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used. The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney transplant patients lowers LDL cholesterol for additional 10 per cent.

Detailed Description
-----------------
In addition to observing the lipid profile the investigators intend to look for other pathophysiological effects of ezetimibe, such as its influence on oxidative stress, endothelial function and inflammatory biochemical markers.

Official Title
-----------------
The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients

Conditions
-----------------
Transplants, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LDL > 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent. Exclusion Criteria: Acute heart disease or any heart disease in the last 3 months, kidney graft failure, active systemic inflammatory disease, active malignant disease, chronic diarrhea and malabsorption, transaminases increased > 3 fold, creatin kinase increased > 5 fold, hypersensitivity reactions, active peptic ulcer disease.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ezetimibe, dyslipidemia, kidney transplant<br> | Drug: Ezetimibe<br>* Patients on standard immunosuppressive therapy with statin will be added ezetimibe for 6 months. Thereafter ezetimibe will be discontinued for three months. Biochemical parameters will be analysed at the time of enrolment, after 3 months, 6 months and 9 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of LDL cholesterol concentration. | The investigators expect the LDL cholesterol concentration to lower for at least 10%. | At enrolment, at three, six and nine months thereafter. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxidative markers | Change in oxidative markers, inflammation and endothelial function. | At enrolment, at three, six and nine months thereafter. |
Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

Study Overview
=================
Brief Summary
-----------------
The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

Detailed Description
-----------------
A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.

Official Title
-----------------
Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study

Conditions
-----------------
Biliary Diseases, Pancreas Diseases

Intervention / Treatment
-----------------
* Procedure: Team 1
* Procedure: Team 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP Exclusion Criteria: previous endoscopic sphincterotomy, surgically altered anatomy (e.g. Billroth II gastrectomy) or diagnostic duodenoscopy

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Other: experienced assistant group<br>experienced endoscopist with an experienced assistant. | Procedure: Team 1<br>* experienced endoscopist with a experienced assistant<br>* Other names: experienced;|
| Other: new trained assistant group<br>same experienced endoscopist with a new trained assistant | Procedure: Team 2<br>* same experienced endoscopist with a new trained assistant<br>* Other names: new trained;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation success rate |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of post-ERCP pancreatitis |  | two years | 
| Incidences of bleeding |  | two years | 
| Incidences of perforation |  | two years | 
| Incidences of infection |  | two years | 
| Number of attempts at cannulation |  | two years | 
| Cannulation time |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C-Hook, Endoscopic retrograde cholangiopancreatography (ERCP), Guidewires, Cannulation, Single-operator
Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Study Overview
=================
Brief Summary
-----------------
Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).

Official Title
-----------------
Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Conditions
-----------------
Neurosurgery

Intervention / Treatment
-----------------
* Drug: Vancomycin
* Drug: Teicoplanin
* Drug: Linezolid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Already having an external CSF drain Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain (shunt) Exclusion Criteria: Infection or colonization requiring other than standard prophylactic antibiotics

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vancomycin<br>Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample | Drug: Vancomycin<br>* Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample<br>|
| Active Comparator: Teicoplanin<br>Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample | Drug: Teicoplanin<br>* Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample<br>|
| Active Comparator: Linezolid<br>Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample | Drug: Linezolid<br>* Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of antibiotics in cerebrospinal fluid | Concentration in CSF past i.v. injection | 1, 2, 4, 6, 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vancomycin, teicoplanin, linezolid, intravenous, cerebrospinal fluid, CSF, pharmacokinetics, penetration, blood-brain barrier, Pharmacokinetics of three antibiotics in relation to cerebrospinal fluid
Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The investigators will use optical coherence tomography to detect the ex-vivo tissue image of surgical removed melanoma or other benign pigmented lesions of skin.

Detailed Description
-----------------
The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe skin tissue images in ex vivo culture. Parts of melanoma or benign pigmented lesions specimens derived from biopsy or surgical excision specimen will be observed by 3D optical tomography. A tiny tissue fragment of melanoma or benign pigmented lesions will be taken from surgical specimen without interference normal pathological evaluation. The location of melanocytic cells in melanoma or benign tissue fragments will be mapped by the 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be dermatological patients who need to surgical intervention.

Official Title
-----------------
Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged older than 20 years old Patients who had melanoma, melanoma in situ, and/or other benign pigmented lesions, Patients who had non-melanoma skin cancers (basal cell carcinoma, or squamous cell carcinoma). Patients who had precancerous skin lesions (Bowen's disease, actinicc keratosis) Exclusion Criteria: • Pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Ex vivo Tissue image. | Partial fragments of tissue specimens from melanoma, melanoma in situ, or other benign pigmented lesions will be used for imaging purpose by a optical coherence tomography. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optical coherence tomography
Validation of the GATE Software

Study Overview
=================
Brief Summary
-----------------
Comparison of the differential luminance sensitivity (DLS) values at each test point

Official Title
-----------------
Validation of the GATE Software for Static Visual Field Examinations

Conditions
-----------------
Visual Field Defects

Intervention / Treatment
-----------------
* Procedure: perimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physical, intellectual and linguistic abilities, in order to understand the test requirements spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt distant visual acuity > 10/20 isocoria, pupil diameter > 3 mm Exclusion Criteria: pregnancy, nursing diabetic retinopathy asthma HIV+ or AIDS history of epilepsy or significant psychiatric disease medications known to effect visual field sensitivity acute ocular infections (e.g. keratitis, conjunctivitis, uveitis) severe dry eyes miotic drugs amblyopia squint nystagmus albinism keratoconus intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening history or presence of macular disease and / or macular edema relevant opacities of central refractive media (cornea, lens, vitreous body) ocular trauma

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 |
| --- | --- |
| Glaucoma<br> | Procedure: perimetry<br>* automated static perimetry with adapted GATE strategy<br>* Other names: Octopus 900;|
| Retinitis pigmentosa (RP)<br> | Procedure: perimetry<br>* automated static perimetry with adapted GATE strategy<br>* Other names: Octopus 900;|
| Anterior Ischemic Optic Neuropathy (AION)<br> | Procedure: perimetry<br>* automated static perimetry with adapted GATE strategy<br>* Other names: Octopus 900;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions. | each participant were examined 2 times at two seperate sessions within 14 days. | up to 14 days |