linjc16/ctgov huggingface dataset:
Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses

Study Overview
=================
Brief Summary
-----------------
This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.

Official Title
-----------------
Insertion Clinical Study to Evaluate the Aberration Characteristics of Kalifilcon A Toric Lenses

Conditions
-----------------
Contact Lens Wearer

Intervention / Treatment
-----------------
* Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation. A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kalifilcon A Daily Disposable Toric LD213001 lens<br>kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D | Device: kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D<br>* kalifilcon A Daily Disposable Toric LD213001 lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical aberration measurement |  | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of Toric Etch Mark by the Investigator |  | 60 minutes |
Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.

Detailed Description
-----------------
We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.

Official Title
-----------------
Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited. Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included. Exclusion Criteria: Acute coronary SD, serum Cr>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Carrotid IMT group according to maximal IMT<br>We defined increased IMT group as whom had maximal IMT ≥ 1.0 mm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. |  | 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods. |  | 17 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis, Carotid IMT, Multidetector CT, Type 2 diabetes
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection

Study Overview
=================
Brief Summary
-----------------
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections

Conditions
-----------------
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee, Infected Spacers

Intervention / Treatment
-----------------
* Drug: CEM-102
* Drug: IV or Oral standard of care antibiotics
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prosthetic knee or hip joint infection Infected joint spacer Able to swallow tablets Able to voluntarily sign the informed consent form Females of childbearing potential must use an acceptable method of birth control The joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin Exclusion Criteria: History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin Females who are pregnant or lactating Requirement for significant immunosuppression Bacteremia Known cirrhosis or decompensated liver disease Current treatment for HIV or Hepatitis C Seizure disorder, requiring anti-convulsants

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEM-102 plus Rifampin<br> | Drug: CEM-102<br> <br> * Other names: fusidic acid;Drug: Rifampin<br> <br> |
| Active Comparator: Standard of Care<br> | Drug: IV or Oral standard of care antibiotics<br> <br> * Other names: co-trimoxazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial eradication of joint infection | Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection. | 3 to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prosthetic joint infection, hip arthroplasty, MRSA, knee arthroplasty
The Attitudes of Doctors Working in the Surgical Clinic of Patient Blood Management

Study Overview
=================
Brief Summary
-----------------
The attitudes of doctors working in the surgical clinic of a university hospital for patient blood management: a survey-based study

Official Title
-----------------
The Attitudes of Doctors Working in the Surgical Clinic of a University Hospital for Patient Blood Management: a Survey-based Study

Conditions
-----------------
a Survey-based Study

Intervention / Treatment
-----------------
* Other: The attitudes of doctors working in the surgical clinic of a university hospital for patient blood management: a survey-based study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Being a doctor working in the surgical clinics of the university hospital Exclusion Criteria: INQUIRING SURVEY QUESTIONS

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The attitudes of doctors working in the surgical clinic of a university hospital for patient blood management: a survey-based study|No intervention required|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The attitudes of doctors working in the surgical clinic of a university hospital for patient blood management: a survey-based study | The approach of physicians working in surgical clinics to patient blood management | about 2 months |
Management of Fournier Gangrene at Ibn Rochd University Hospital Center

Study Overview
=================
Brief Summary
-----------------
Case series with retrospective data collection of patients treated for Fournier's gangrene between January 2010 and March 2017. The main etiologies, risk factors, postoperative complications outcomes and long term follow up results were analyzed.

Detailed Description
-----------------
Eight four (84) patients were recruited. The average age of our patients was 49 years (with limits of 20 to 76), the male gender dominates our series (83.33%) with a sex ratio of 5M / 1W, the most frequently found risk factor was diabetes mellitus (37%). The most common etiology was anal abscesses (32%). The average time to consultation was 8 days (limits ranges from 3 to 30 days). All patients were admitted at a necrosis stage (100%). Anemia was identified in 85% of cases. The low platelets were noticed in 44.03% of cases. Hypoalbuminemia was found in 93% of cases. All patients (100%) benefited resuscitation initially and antibiotic therapy on their admission. They received emergency surgical debridement with a cleansing stoma. The average length of hospital stay was 13 days and complications occurred in 33% of cases. The mortality rate was 7.14%. then we conclude that Fournier's gangrene is a medico-surgical emergency with a high morbidity and mortality rate. Early diagnosis as well as antibiotic therapy and the quality of debridement save the patients.

Official Title
-----------------
Fournier's Gangrene: Seven Years of Experience in the Emergencies Service of Visceral Surgery at Ibn Rochd UHC

Conditions
-----------------
Fournier Gangrene

Intervention / Treatment
-----------------
* Procedure: Necrotesectomy associated with cleanleness stoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Fournier Gangrene Exclusion Criteria: Other perineal diseases which are differential diagnosis of Fournier gangrene

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Necrotesectomy associated with cleanleness stoma|Excision of all necrotised tissues after stool diversion and wound dressing using|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who died for fournier gangrene | The mortality rate of patients with Fournier Gangrene after six months | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fournier's Gangrene, stoma, necrosectomy
Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations. If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality. Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.

Official Title
-----------------
Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis

Conditions
-----------------
Patient's With Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Radiation: Ultrasound and MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult-onset disease. Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis. Exclusion Criteria: Any patient with any collagen disease rather than Rheumatoid arthritis. Patients with joints deformities. Patient's with implanted metal clips or wires or artificial pacemaker.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases<br> | Radiation: Ultrasound and MRI<br>* Ultrasound examination and magnetic resonance imaging on the hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of Ultrasound and MRI in Rheumatoid Arthritis of the hand | determine the diagnostic value and associated weakness and strength aspects of hand ultrasound versus MRI in patients with rheumatoid arthritis, particularly in early disease. | 3 months |
Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study

Study Overview
=================
Brief Summary
-----------------
A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. The most common surgical procedure in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin. This method, however, has some problems regarding healing and recidives. Therefore this study is comparing the standard excision procedure to another surgical procedure, laying open. Healing frequency is the main variable, but postoperative pain, sick leave time and patient satisfaction is also measured.

Official Title
-----------------
Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: Laying open
* Procedure: Sinus excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pilonidal sinus eligible for surgery Age > 18 years Swedish speaking Exclusion Criteria: Active signs of infection prohibiting primary sewing of the wound

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 |
| --- | --- |
| Experimental: Laying open<br> | Procedure: Laying open<br>* Laying open Antibiotics Dalacin 300 mg tablets or iv infusion 600 mg<br>|
| Active Comparator: Sinus excision<br> | Procedure: Sinus excision<br>* Sinus excision Antibiotics Dalacin tablets 300 mg or iv infusion 600 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing frequency |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain according to a visual analogue scale |  | 7 days | 
| scar/wound length |  | 12 months |
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

Detailed Description
-----------------
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Official Title
-----------------
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Primary Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Livalo, Ezetrol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary hypercholesterolemia Exclusion Criteria: The subject not meet the specified LDL-C level

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Livalo 2mg, Ezetrol 10mg<br>Pitavastatin 2mg, Ezetimibe 10mg | Drug: Livalo, Ezetrol<br>* Pitavastatin+Ezetimibe Pitavastatin<br>* Other names: Pitavastatin, Ezetimibe;|
| Active Comparator: Livalo 2mg<br>Pitavastatin 2mg | Drug: Livalo, Ezetrol<br>* Pitavastatin+Ezetimibe Pitavastatin<br>* Other names: Pitavastatin, Ezetimibe;|
| Experimental: Livalo 4mg, Ezetrol 10mg<br>Pitavastatin 4mg, Ezetimibe 10mg | Drug: Livalo, Ezetrol<br>* Pitavastatin+Ezetimibe Pitavastatin<br>* Other names: Pitavastatin, Ezetimibe;|
| Active Comparator: Livalo 4mg<br>Pitavastatin 4mg | Drug: Livalo, Ezetrol<br>* Pitavastatin+Ezetimibe Pitavastatin<br>* Other names: Pitavastatin, Ezetimibe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in LDL-C level from baseline at Week 8 | change in LDL-C level | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C level from baseline at Week 4 and Week 8 | change in LDL-C level | Week 4 and Week 8 |
Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to collect data from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin® for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi Syndrome.

Official Title
-----------------
Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS)

Conditions
-----------------
Prader-Willi Syndrome, Genetic Disorder

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities Genetically diagnosed Prader-Willi Syndrome Received at least one dose of Norditropin® treatment Pre-pubertal at start of treatment; assessed by Tanner stage 1, or testicular volume below 4ml (according to Tanner 1976) Exclusion Criteria: Pre-treatment with other Growth Hormone preparation prior to treatment with Norditropin®

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| A<br> | Drug: somatropin<br>* Prader-Willi syndrome children treated with at least one dose of Norditropin®<br>* Other names: Norditropin®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective is to investigate changes in height Standard Deviation Score (SDS) |  | in response to 12 months Norditropin® treatment in children with PWS (referenced to PWS population | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1) |  | at 12 months- and at last observation during Norditropin treatment | 
| Change in body composition (DEXA, Bio impedance or stable isotope dilution) |  | at 12 months- and at last observation during Norditropin treatment | 
| Height velocity (HV) and change in HV |  | at 12 months- and at last observation during Norditropin treatment | 
| Glycated Fraction of Haemoglobin (HbA1c) |  | at 12 months- and at last observation during Norditropin treatment | 
| Insulin-Like Growth Factor-I (IGF-I) |  | at 12 months- and at last observation during Norditropin treatment | 
| Haematology |  | at 12 months- and at last observation during Norditropin treatment | 
| Thyroid-stimulating hormone (TSH) and active form of free thyroxin |  | at 12 months- and at last observation during Norditropin treatment | 
| Adverse Events. |  | at 12 months- and at last observation during Norditropin treatment |