linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brimonidine ophthalmic solution 0.1%
* Drug: Brimonidine ophthalmic solution 0.2%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular hypertension or glaucoma in both eyes Exclusion Criteria: Uncontrolled systemic disease Known allergy or sensitivity to brimonidine

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Brimonidine ophthalmic solution 0.1% | Drug: Brimonidine ophthalmic solution 0.1%<br>* 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)<br>|
| Active Comparator: 2<br>Brimonidine ophthalmic solution 0.2% | Drug: Brimonidine ophthalmic solution 0.2%<br>* 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)<br>* Other names: ALPHAGAN®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) |  | Week 2 - Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  | Month 6 - Month 12 |
New Heart Failure Biomarkers in Early Stage Chronic Kidney Disease-Mineral and Bone Disorder

Study Overview
=================
Brief Summary
-----------------
the objective of this study is to : -Determinate wether the circulating levels of iFGF23 and klotho can be a predictor biomarker of HF in patients with CKD-MBD.

Detailed Description
-----------------
The disorders of mineral metabolism and bone disease are common complications in CKD patients and they are associated with increased morbidity and mortality. Abnormalities of the vasculature are seen in early CKD, producing vascular stiffness contributing to left ventricular hypertrophy and its pathophysiology involves newly discovered hormones, such as the fibroblast Growth factor 23 (FGF23) and α- klotho. The FGF receptor and its co-receptor klotho moderate these effects. FGF23 levels inflate early in in the advancement of CKD stage to attain levels in CKD stage 5D. But we still have few knoweledges if these markers can have some drawbacks for predicting CVD in early stage CKD.

Official Title
-----------------
Heart Failure and Early Stage Chronic Kidney Disease -Mineral Bone Disorder : the Importance of the New Biomarkers

Conditions
-----------------
Kidney Disease, Chronic, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early CKD stage Heart failure Exclusion Criteria: Infections cancer corticoid therapy renal replacement therapy Advanced CKD stage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure (HF)<br>subjects with a Left Ventricular Ejection Fraction (LVEF) <50% or LVEF >50% and E/e'>10. | |
| No Heart Failure (NHF)<br>subjects with LVEF>50% | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibroblast Growth Factor 23 (FGF23) | compare the circulating levels of FGF23 (pg/ml) in the two groups . | completed data base (after 4 months) | 
| Alpha Klotho | compare the circulating levels of klotho (ng/ml) in the two groups . | completed data base (after 4 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FGF23, klotho, Mineral Bone Disorder
Stem Cell Therapy in Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.

Official Title
-----------------
The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Biological: Stem Cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age group of 3-25 years Duchenne muscular dystrophy diagnosed on the basis of clinical presentation Exclusion Criteria: presence of respiratory distress presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus malignancies acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction < 30% pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 25 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: Stem Cell<br>bone marrow mononuclear cell transplantation | Biological: Stem Cell<br>* Intrathecal autologous bone marrow mononuclear cell transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Muscle Testing |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brooke and Vignos Scale |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne muscular dystrophy, Autologous Bone marrow Mononuclear cell therapy, Stem Cells
Positional Cloning of the Gene(s) Responsible for Alagille Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. In a collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase chromosomes and genomic DNA from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. Characterization of genes involved in Alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease. Recently, we and others found that mutations in Jagged1, a Notch1 receptor are responsible for Alagille Syndrome.

Detailed Description
-----------------
The goal of the project is to identify and clone the gene(s) responsible for the Alagille Syndrome (AGS) by a positional cloning approach. The first step towards this goal is to define the smallest genomic candidate region for AGS at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. In a collaborative effort with clinician-investigators studying the Alagille syndrome, metaphase chromosomes and genomic DNA from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. Characterization of genes involved in Alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease.

Official Title
-----------------
Positional Cloning of the Gene(s) Responsible for Alagille Syndrome

Conditions
-----------------
Alagille Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
All enrolled affected subjects, whose samples will be analyzed in this study, must meet the criteria for the clinical diagnosis of Alagille Syndrome (Syndromic Bile Duct Paucity) which include liver biopsy findings consistent with Alagille Syndrome and at least 3 of the 5 primary clinical criteria: cholestasis, characteristic face, posterior embryotoxon, butterfly vertebrae and cardiac findings.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Map, Chromosomal Deletion, Mutations, Paucity of Bile Ducts, Transcript Identification, Alagille Syndrome, Syndromic Bile Duct Paucity
Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the prevalence of genetic polymorphisms in adults with iron deficiency and anemia, and the responses to two different treatments: iron sulphate and a composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will be hemoglobin, measured before and after 6 weeks.

Official Title
-----------------
Prevalence of Genetic Polymorphisms of DMT1 and Ferroportin Enzymes in Adults With Anemia by Iron Deficiency, and Its Influence on the Efficacy of Conventional and Herbal Treatments

Conditions
-----------------
Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Drug: Herbal medicine
* Drug: Iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 y and < 50 y A diagnostic of iron deficient anemia Exclusion Criteria: Severe anemia Treatment interruption for more than 25% of the 6 weeks New onset severe adverse symptoms or events Patient's request

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron<br> | Drug: Iron<br>* Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.<br>|
| Experimental: Herbal<br> | Drug: Herbal medicine<br>* Patients will receive a combination of Hibiscus sabdariffa (powdered dry plant), 200 mg, BID, and Centella asiatica tincture, 40 drops, BID, for 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Hemoglobin will be measured before treatment and after 6 weeks of treatment | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron, anemia, herbal medicine, phytotherapy, Centella asiatica, Hibiscus sabdariffa
Intramedullary Fixation of Humerus Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.

Detailed Description
-----------------
The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.

Official Title
-----------------
A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures

Conditions
-----------------
Humeral Fractures, Pathological Fractures

Intervention / Treatment
-----------------
* Device: Quantum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years old. Mid shaft diaphyseal fracture Acute fracture Exclusion Criteria: Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes. Ongoing infection in fracture site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Quantum<br>In this single arm study, the Quantum nailing system will be used in all patients. | Device: Quantum<br>* Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone union and callus formation |  | up to 6 months | 
| Bone alignment |  | up to 6 months | 
| Nail and screws resistance over time |  | up to 6 months |
Investigation Into the Correlation of Plasma Hs-CRP Concentrations and Cardiovascular Risk in Korean Population

Study Overview
=================
Brief Summary
-----------------
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.

Official Title
-----------------
Investigation Into the CorrelAtion of pLasma Hs-CRP Concentrations and cardiovascuLar rISk in Korean populaTiOn

Conditions
-----------------
hsCRP

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with at least one clinic visit record within the last 12 months from the date of data entry. Subjects with at least one hs-CRP level measured within the last 12 months from the date of data entry. Exclusion Criteria: Use of statins or other lipid-lowering therapies including fibrates, niacin, and bile acid sequestrants in the past 3 months prior to hsCRP measurement Active inflammatory diseases documented during the period of CRP measurement Subjects taking immunosuppressants Findings of chronic inflammation: arthritis, lupus, or inflammatory bowel 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients who have records of clinic visit with circulatory and endocrine internal medicines of nationwide tertiary hospitals within the last one year. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate hs-CRP levels according to risk categories by the NCEP ATP III. |  | Within the last 12 months from the date of data entry. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate a relationship between hs-CRP and each CHD CVD risk factor including LDL-C. |  | Within the last 12 months from the date of data entry. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hsCRP
High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals

Study Overview
=================
Brief Summary
-----------------
High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good differentiation between nerve and surrounding tissues within foramen und allows to reliably quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery and its relation to neural structures / foramina can be assessed.

Official Title
-----------------
High-resolution MRI (7 Tesla) of the Cervical Spine in Asymptomatic Individuals - Development of Reference Standards

Conditions
-----------------
Magnetic Resonance Imaging, Cervical Spine Anatomy, Reference Standard

Intervention / Treatment
-----------------
* Diagnostic Test: 7 Tesla MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent as documented by signature (Appendix Informed Consent Form) >18 years old no cervical back pain Exclusion Criteria: previous surgery tumor patients pregnancy or breast feeding any MRI contra-indications

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 7 Tesla MRI|7 Tesla MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment | measure the diameter of the neuroforamen (in mm) and the diameter of each cervical nerve root/ganglion within the neuroforamen (in mm) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation of vertebral artery to neural structures - assessment of contact between ganglion/spinal nerve and vertebral artery by assessing the presence of fat tissue between these structures. | to assess if there is contact between the vertebral artery and the ganglion/spinal nerve at each segment and each side if no fat tissue is interposed between the ganglion and vertebral artery it is classified as having contact. If contact is present, the length of contact (in mm) will be measured in the axial plane. | 1 year |
Efficacy and Tolerability of Angeliq in Thai Women

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
A Multi-Center, Open-Label, Non-Comparative Study Investigating the Efficacy and Tolerability of Angeliq® in Postmenopausal Thai Women With Vasomotor Symptoms Over Three 28-Day Treatment Cycles

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: Estradiol/DRSP (Angeliq, BAY86-4891)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with hot flushes Exclusion Criteria: Women with a contraindication for Hormone Replacement Therapy (HRT)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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: Arm 1<br> | Drug: Estradiol/DRSP (Angeliq, BAY86-4891)<br>* 1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative change in the frequency of hot flushes |  | At baseline, week 4, 8, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in intensity of hot flushes |  | At baseline, week 4, 8, 12 | 
| The relative change in frequency of hot flushes |  | At baseline, week 4, 8 | 
| The change in intensity of hot flushes |  | At baseline, week 4, 8 | 
| The proportions of subjects with urogenital symptoms |  | At baseline, week 4, 8, 12 | 
| Bleeding pattern |  | At baseline, week 4, 8, 12 | 
| Adverse events collection |  | Collection of AE throughout the study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopause