linjc16/ctgov huggingface dataset:
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI (ST-segment Elevation Myocardial Infarction)

Official Title
-----------------
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intravenous Single Injection LC28-0126 Immediately Before PCI (Percutaneous Coronary Intervention) in Patients With STEMI(ST-segment Elevation Myocardial Infarction)

Conditions
-----------------
ST-segment Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: LC28-0126 Dose A
* Drug: LC28-0126 Dose B
* Drug: LC28-0126 Dose C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 75 Within 12 hours after the onset of chest pain ST-segment elevation of more than 0.1 mV in two contiguous leads or new LBBB(left bundle-branch block) patients Signed for written informed consent Exclusion Criteria: Left Main disease Multi-vessel disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: LC28-0126 Dose A<br>LC28-0126 Dose A | Drug: LC28-0126 Dose A<br>* LC28-0126 Dose A<br>|
| Experimental: LC28-0126 Dose B<br>LC28-0126 Dose B | Drug: LC28-0126 Dose B<br>* LC28-0126 Dose B<br>|
| Experimental: LC28-0126 Dose C<br>LC28-0126 Dose C | Drug: LC28-0126 Dose C<br>* LC28-0126 Dose C<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of CK-MB for 72 hours post PCI |  | pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Troponin I and CK for 72h post PCI |  | pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h | 
| Infarct size and myocardial function assessed by CMR and Echocardiogram |  | Day 4, 30 |
Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.

Official Title
-----------------
Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)

Conditions
-----------------
Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Drug: GS-5806
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female Between 18 to 45 years old Body Mass Index of 18 to 33 kg/m2 Exclusion Criteria: Acute or chronic medical illness Positive for Human Immunodeficiency Virus, Hepatitis B or C Nose or nasopharynx abnormalities Abnormal lung function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS-5806<br>GS-5806, powder for oral solution | Drug: GS-5806<br>* GS-5806, powder for oral solution<br>|
| Placebo Comparator: Sugar powder for oral solution in juice<br>Sugar powder for oral solution | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load measurements. | Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12. | Post initial dose of GS-5806/placebo to Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline symptoms | Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12 | Innoculation through Day 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory, Syncytial, Virus, Infections, RSV
Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
In men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.

Official Title
-----------------
Chemohormone Therapy Prior to Prostatectomy in High Risk Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk prostate cancer without evidence of bone metastasis.

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

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

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

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

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
-----------------
Prostate cancer, chemotherapy, hormone therapy, surgery, PSA, Gleason score
Acne Treatment With Active Oplon's Patches - 15-18 Years Old

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Detailed Description
-----------------
Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

Official Title
-----------------
Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: Oplon Active Patch
* Device: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne Vulgaris Over 15 years Signing informed consent Exclusion Criteria: Active treatment of acne Change in hormonal therapy Antibiotic treatment in a week prior to the experiment Sensitive skin Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Oplon Active Patch<br> | Device: Oplon Active Patch<br>* Patches are placed over acne lesion overnight. Treatment is a single treatment.<br>|
| Placebo Comparator: Placebo Comparator: Placebo patch<br> | Device: Placebo Patch<br>* same as active patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Score of lesion | Lesions were ranked by investigator according to severity whereas: 0-clear, 1-mild, 2-moderate, 3-sever | Severity Score of lesion [Time Frame: 24 hours following patch removal] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Score of lesion | Lesions were ranked by investigator according to severity whereas: 0-clear, 1-mild, 2-moderate, 3-sever | Severity Score of lesion [Time Frame: 12 hours with the patch] |
Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control.

Conditions
-----------------
Diabetic Retinopathy, Glaucoma, Neovascular

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥18 years PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle) Exclusion Criteria: intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy previous intravitreal injection of ranibizumab or bevacizumab in either eye previous intravitreal corticosteroids injection in either eye pregnancy or current oral contraceptive intake usage of clopidogrel bisulfate or coumadin uncontrolled hypertension and cardiac disease uncontrolled renal or liver 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 |
| --- | --- |
| Experimental: ranibizumab<br> | Drug: ranibizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitreous hemorrhage |  | 12 months | 
| intraocular pressure |  | 12 months |
Seroma Prevention After Body Contouring Procedures

Study Overview
=================
Brief Summary
-----------------
With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.

Official Title
-----------------
Prevention of Seroma Formation After Body Contouring Procedures

Conditions
-----------------
Seroma, Abdominoplasty, Complication of Surgical Procedure

Intervention / Treatment
-----------------
* Procedure: Variable drain usage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study Exclusion Criteria: Minors or patients with a designated health care proxy, revision surgeries, morbid obesity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| No Intervention: Suction drain<br>Conventional body contouring procedure, application of Redon suction drains, drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7 | |
| Active Comparator: Passive drain<br>Conventional body contouring procedure, application of drains without suction (passive drainage), drain removal when output is less than 30 ml in 24 hours or at the latest on postoperative day 7 | Procedure: Variable drain usage<br>* Influence of drain usage on seroma formation rate<br>|
| Active Comparator: No drain<br>Conventional body contouring procedure, no application of drains | Procedure: Variable drain usage<br>* Influence of drain usage on seroma formation rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of seroma formation | As primary outcome this study measures the rate of seroma requiring evacuation via puncture aspiration (fluid retention > 20 cc) in each group. | Weekly follow-up until postoperative week 6. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drain usage
One-year Outcome After Prehospital Intubation

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician.

Detailed Description
-----------------
The aim of helicopter emergency medical services (HEMS) is to supplement ground EMS units in the care of prehospital patients. The need for advanced airway management in critical out-of-hospital patients can be considered as one indicator of the severity of the patient's condition. A recent European initiative suggested advanced airway management to be included in the top five research priorities for physician-provided prehospital care.To our knowledge, no previous studies describe the long-term outcome of critical prehospital patients treated by an EMS physician. The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician. Our secondary aims were to determine the indications and causes for EMS physician performed prehospital endotracheal intubation.

Official Title
-----------------
One-year Outcome After Prehospital Intubation

Conditions
-----------------
One-year Outcome After Prehospital Intubation

Intervention / Treatment
-----------------
* Procedure: Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All non-cardiac arrest patients. Exclusion Criteria: Patients with a known need for personal assistance in activities of daily life prior to the incident leading to prehospital intubation (outcome evaluation). Patients intubated by EMS before HEMS arrival. Death on scene or during transportation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HEMS treated patients<br>Patients whose airways were secured by the HEMS physician. | Procedure: Intubation<br>* HEMS physician prehospital intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Score (GOS) | GOS 1 = Death GOS 2 = Poor neurological outcome GOS 3 = Good neurological outcome Modified from the original 5 - step classification. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prehospital emergency care (MeSH), Emergency medical services (MeSH), Helicopter emergency medical service, Critical care (MeSH), Airway management (MeSH), Endotracheal intubation (MeSH), Patient outcome
Ability of Patients With Low Vision to Properly Instill Eye Drops

Study Overview
=================
Brief Summary
-----------------
The investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes. The investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population. The investigators aim to explore whatever factors may be involved in preventing this population from getting prescribed eyedrops into their eyes, whether it is more related to visual field or visual acuity.

Detailed Description
-----------------
This is a study that involves a questionnaire that a study participant fills out, detailing their experience with eyedrops (if any), followed by a video recording of them instilling artificial tears into their worse-seeing eye, with their dominant hand. Patients must have visual acuity worse than 20/60 in at least one eye, and/or have a recent visual field that demonstrated Hodapp criteria for Moderate or Severe visual field damage. This is an observational study of how patients with low vision due to either glaucoma or retinal disease instill eyedrops. Each video will be graded by the principal investigator for success at instilling eyedrops, and patients will be stratified by their visual acuity or visual field, and whether they have a primary diagnosis of glaucoma or retinal disease.

Official Title
-----------------
Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops

Conditions
-----------------
Glaucoma, Retinal Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ETDRS visual acuity 20/60 or worse Exclusion Criteria: Unwilling to participate Light perception vision No light perception vision

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma patients<br>This is a group of patients with restricted visual fields or ETDRS visual acuity of 20/60 or worse | |
| Retina patients<br>A group of patients with retinal pathology(ARMD, CME, diabetic retinopathy) contributing to their decreased vision. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful instillation of a single eyedrop onto the surface of the eye |  | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
compliance, eyedrop instillation, How patients with low vision due to glaucoma or retinal pathology instill eyedrops into their own eyes.
Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

Official Title
-----------------
Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Conditions
-----------------
Foetal Growth Problem, Small for Gestational Age

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the GHRETARD/BPD/20/NL trial Written informed consent from child and/or parents/guardians before continuation in the extension trial

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 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: Low dose<br> | Drug: somatropin<br>* 3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily<br>|
| Experimental: High dose<br> | Drug: somatropin<br>* 3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear growth (height during childhood) |  |  | 
| Final height |  |  | 
| Bone maturation |  |  | 
| Pubertal development |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  |