linjc16/ctgov huggingface dataset:
Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF

Study Overview
=================
Brief Summary
-----------------
This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.

Official Title
-----------------
A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: ATG003 (mecamylamine)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 55 years of age clinical diagnosis of neovascular AMD Exclusion Criteria: confounding ocular condition

Ages Eligible for Study
-----------------
Minimum Age: 56 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 |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo eyedrops, BID, 48 weeks<br>|
| Experimental: ATG003<br> | Drug: ATG003 (mecamylamine)<br>* 1% Ophthalmic solution, eyedrop BID, 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) |  | Day 1 - Week 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of ATG003 |  | Day 1 - Week 50 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wet AMD, Comentis, ATG003, mecamylamine
Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to observe the efficacy of electrical vestibular nerve stimulation in the management of obesity. Allocation: Active device (participants act as their own self-control) Endpoint classification: Efficacy Study. The study provides further evidence for the efficacy of electrical vestibular nerve stimulation in the management of obesity.

Official Title
-----------------
Electrical Vestibular Nerve Stimulation (VeNS) Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Reducing Excess Body Weight.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Vestal device
* Behavioral: Lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 30 to 40 kg/m2 Aged above 18 years Exclusion Criteria: Current use of any medications or therapy including use of oral contraceptives Use of dietary supplements known to affect the BMI Ear problems (assessed during physical examination) Any severe complications Unwilling participants

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Bilateral electrical vestibular nerve stimulation will be administered using a battery-powered vestibular nerve stimulator (ML 1000). Participants will act as their own self-control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestal active device<br>10 subjects to receive an active device plus a diet plan for 12 weeks. | Device: Vestal device<br>* Battery powered non-invasive neurostimulation device<br>Behavioral: Lifestyle intervention<br>* All subjects will be prescribed a diet plan and instructed to follow it for the duration of the 12-week study. The diet plan will be designed by the P.I. who is a qualified, obesity management coach.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Blood sample to calculate ratio of Total Cholesterol: HDL and LDL | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function tests | Albumin test | 12 weeks | 
| Complete blood count | Complete blood count | 12 weeks | 
| Glycated hemoglobin | HbA1c as a percentage | 12 weeks | 
| Mean blood glucose | Fasting glucose in mg/dL | 12 weeks |
Cardiac Rehabilitation in Cardiomyopathies

Study Overview
=================
Brief Summary
-----------------
This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life in patients after cardiac rehabilitation associated with the diaphragmatic muscle training.

Official Title
-----------------
The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy

Conditions
-----------------
Cardiomyopathies

Intervention / Treatment
-----------------
* Other: Cardiac Rehabilitation with diaphragmatic muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Cardiomyopathies in functional class III or IV (New York Heart Association) Aged over 18 years Body mass index below 30 kg/m2 Exclusion Criteria: Confused and depressed patients Cardiac instability and worsening dyspnea after initiation of treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Rehabilitation<br>9 patients with cardiomyopathy in functional class III or IV, submitted to an 8-week program with exercises and respiratory muscle training. | Other: Cardiac Rehabilitation with diaphragmatic muscle training<br>* Stretching and aerobic exercises and respiratory muscle training with a Threshold ® device, with load of 40% of the maximal inspiratory pressure (MIP), two times a week during one hour.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of a cardiac rehabilitation in patients with cardiomyopathy, evaluating the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life. |  | 8 weeks / Twice a week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, dyspnea, strength
Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports

Study Overview
=================
Brief Summary
-----------------
Inhospital the blood transfusion process consists of many phases: ordering the blood product, analysis of the blood sample, delivery, transport and storage of the blood product and administration. In each of these phases (near) accidents may occur. A severe transfusion incident refers to the transfusion of a wrong blood product, whereas a near miss is detected before transfusion. In 2010 the University Hospitals Leuven introduced a new electronic patient incident report system for transfusion events. In this study the investigators will analyze the reported blood transfusion events to detect the most common causes of blood transfusion events and the weakest link in the blood transfusion chain.

Detailed Description
-----------------
A retrospective survey will be conducted of all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012. Both severe accidents and near misses will be included. Data will be drawn from the incident report system. Data concerning the number of transfused blood products will be required from the Medical Administration Service. Events will be classified according to the severity and the cause of the event. The different settings where the events took place will be compared using a chi-square test (p<0,05).

Official Title
-----------------
Common Causes of Blood Transfusion Events in a University Hospital: Analysis of Incident Reports.

Conditions
-----------------
Blood Transfusion Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all transfusion events reported in the University Hospitals Leuven between January 2011 and July 2012 Both severe accidents and near misses were included Exclusion Criteria: Transfusion reactions
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 |
| --- | --- | --- |
| Severity of inhospital blood transfusion events | included events will be classified into near misses or severe incidents | up to 1,5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of inhospital blood transfusion events | Events are classified into human error, technical problems, deficiency of the blood product and others. Events will also be classified considering the phase in the blood transfusion process. Causes will be studied hospital wide and per setting were the event took place. | up to 1,5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood transfusion, adverse event, incident reporting
Effect of Growth Hormone in Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Official Title
-----------------
Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Conditions
-----------------
Growth Hormone Disorder, Growth Hormone Deficiency in Children, Growth Disorder, Idiopathic Short Stature

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically suspected GHD Height < -2.0 SDS Serum IGF-I less than or equal to -1.0 SDS Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls. Puberty Tanner Stage I Exclusion Criteria: Previous use of growth hormone Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.) Intrauterine growth retardation: birth weight < 3rd percentile. Administration of other growth-altering medications. Evidence of any malignancy or intracranial tumors.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 15 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in height standard deviation score |  | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-I |  |  | 
| IGFBP-3 |  |  | 
| free IGF-I |  |  |
Treatment of Acute HIV Infection to Preserve Immune Function

Study Overview
=================
Brief Summary
-----------------
While most people with HIV experience significant destruction of their immune systems, some people appear to have preserved immune function and can control the virus without drugs. Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to control the virus once the drugs are stopped. This study will evaluate the immune system response of HIV infected people who are treated with anti-HIV drugs soon after being infected.

Detailed Description
-----------------
Studies have identified a potent CD4 T helper (Th) cell response in some infected people, and have shown a correlation between virus-specific Th cells and low levels of viremia. Early institution of potent antiviral therapy in the earliest stages of acute HIV infection have led to strong Th cell responses, analogous to those seen in people who are able to control viremia in the absence of antiviral therapy. This may be because potent antiviral therapy is able to protect virus-specific Th cells as they become activated, and thus these cells are not lost in the earliest stages of infection. This study will characterize the immune response of patients with acute HIV infection who receive antiretroviral therapy and will determine the effects of interruption of therapy in those people who have immune responses to HIV that are similar to patients with long-term non-progressing infection. Participants in this study will be followed through June 2004. Study visits vary from only once to every month and are scheduled at the discretion of the study officials. Study visits include an interview and blood tests.

Official Title
-----------------
Immune Control of HIV Replication

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Acute HIV infection

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune system, Helper T-Cells, Acute Infection, Treatment naive
iOCT for Patients With Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT

Detailed Description
-----------------
48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.

Official Title
-----------------
iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Device: intraoperative OCT
* Device: stand-alone OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract with the indication for surgery (visual symptoms) for both groups (study and control group) Diabetic macula edema - for the study group Age 21 and older written informed consent prior to surgery Exclusion Criteria: Any relevant corneal disease In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>only patients with diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery | Device: intraoperative OCT<br>* before and after surgery intraoperative OCT is performed<br>Device: stand-alone OCT<br>* before and after surgery stand-alone OCT is performed<br>|
| Sham Comparator: controll group<br>only patients without diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery | Device: intraoperative OCT<br>* before and after surgery intraoperative OCT is performed<br>Device: stand-alone OCT<br>* before and after surgery stand-alone OCT is performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness | macular thickness is measured with the central subfield thickness function | 2 hours |
A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.

Official Title
-----------------
An Open-label, Two-treatment, Two-period, Two-sequence, Crossover Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Fimasartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 45 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: known allergy to Fimasartan and atorvastatin existing cardiac or hematological diseases existing hepatic and renal diseases existing gastrointestinal diseases acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 2 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group B<br>Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days) | Drug: Atorvastatin<br> <br> Drug: Fimasartan<br> <br> |
| Other: Group A<br>Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days) | Drug: Atorvastatin<br> <br> Drug: Fimasartan<br> <br> |

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
-----------------
Fimasartan, Atorvastatin
New Method for Distal Interlocking of Cannulated Intramedullary Nails

Study Overview
=================
Brief Summary
-----------------
We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study. Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:The Guiding star method. The allocation will be random.

Official Title
-----------------
New Method for Distal Interlocking of Cannulated Intramedullary Nails

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Device: The Guiding Star
* Device: fluoroscopy (OEC 9800 - General Electric)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signing Informed consent. Conscious patients. Exclusion Criteria: Hemodynamic Instability. Multiple system injuries. Pregnancy. Soldiers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: The Guiding Star<br> <br> |
| Active Comparator: 2<br> | Device: fluoroscopy (OEC 9800 - General Electric)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the outcome will be asses using regular fluoroscopy in the operation room. |  |  | 

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