linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine. There is a 12-week follow-up period. AEs will be recorded throughout the study.

Official Title
-----------------
A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

Conditions
-----------------
Safety

Intervention / Treatment
-----------------
* Device: GP0045
* Device: Restylane Lyft Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study Signed and dated informed consent to participate in the study, including photo consent Men or non-pregnant, non-breast feeding women aged 18 years or older Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable HA gel Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) Participation in any other clinical study within 30 days before treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects<br>Treatment with both GP0045 and Restylane Lyft Lidocaine | Device: GP0045<br>* Hyaluronic acid gel<br>Device: Restylane Lyft Lidocaine<br>* Hyaluronic acid gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045 | Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyaluronic Acid, Lidocaine
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Study Overview
=================
Brief Summary
-----------------
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Detailed Description
-----------------
NAP

Official Title
-----------------
Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Conditions
-----------------
Partial Epilepsy

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine XR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Able to provide written informed consent and agree to comply with study procedures. Male or female aged 18 to 66 years, inclusive. Successful completion of the 804P301 study. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication [SM] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician. Exclusion Criteria Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oxcarbazepine XR<br>Open Label Study | Drug: Oxcarbazepine XR<br>* Open Label Study<br>* Other names: SPN-804O;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Seizure Rate | Measured as change from baseline to end of study | one year |
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify the platelet defect responsible for the bleeding in families from our inherited platelet disorders Israeli-Palestinian registry. The investigators plan to characterize platelet proteome expression after removing high abundance proteins. The investigators will compare the proteome of sick and healthy members of families with inherited platelet disorders, and identify and validate structural proteins, signaling cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The investigators expect to discover new key findings that allow better understanding of human platelet function and allow better diagnosis and treatment of patients with inherited platelet function disorders.

Official Title
-----------------
Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder

Conditions
-----------------
Inherited Platelet Disorders

Intervention / Treatment
-----------------
* Other: Blood collection for platelet protein samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of inherited platelet disorders in the family Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 85 Years

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

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

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 |
| --- | --- |
| Experimental: platelet disease<br>patients with inherited platelet disorders | Other: Blood collection for platelet protein samples<br> <br> |
| Experimental: Healthy<br>Healthy family members of patients with inherited platelet disorders | Other: Blood collection for platelet protein samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of detectable platelet proteins | Characterize platelet proteome expression profile | 2014-2015 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in protein expression from sick and healthy platelets | Analysis of platelet proteome of sick and healthy members of families with inherited platelet disorders | 2015-2019 (4 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inherited platelet disorders, proteome
Short and Long Term Prognosis of Patients Admitted to the ED With Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
Heart failure (HF) is the leading cause of hospitalization ,rehospitalization and mortality for adults over 65 years of age. This study aimed to assess mortality, and hospitalization rates at 30 days and one year after dicharge of patients with heart failure (HF) with reduced ejection fraction (HFrEF) compared to HF with preserved ejection fraction (HFpEF).

Official Title
-----------------
Short and Long Term Prognosis of Patients Admitted to the Emergency Department With Acute Heart Failure

Conditions
-----------------
Acute Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to the ED of Monastir with a principal discharge diagnosis code for HF. Exclusion Criteria: Pregnant or breast feeding women. Alteration of consciousness GCS < 15 Critically ill patients needing immediate mechanical hemodynamic of ventilatory support. Inability to follow instructions or comply with follow-up procedures.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or readmission rates | A composite outcome of Death or readmission within 365 days of hospital discharge | within 365 days after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or readmission rates | A composite outcome of Death or readmission within 30 days of hospital discharge | within 30 days after hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute heart failure prognosis
Anecortave Acetate Versus Placebo in AMD Patients Following PDT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.

Official Title
-----------------
Anecortave Acetate Versus Placebo in AMD Patients Following PDT

Conditions
-----------------
AMD

Intervention / Treatment
-----------------
* Drug: anecortave acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMD disease Exclusion Criteria: Age

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anecortave acetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from the baseline in logMAR visual acuity score at Month 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV. |  |  |
Growth Hormone Use in Cystic Fibrosis - a Multicenter Study

Study Overview
=================
Brief Summary
-----------------
Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies by our group and others have shown that human recombinant growth hormone (GH) improves height velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive results have prompted us to ask further questions regarding GH use in CF including: a) Do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function?, b) Does GH use improve the patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained? We hypothesize that GH treatment in CF patients will improve their clinical status and their quality of life. We further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function, and that positive outcome will be sustained for at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit 40 prepubertal children from five CF centers across the United States (8 per center). Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either the first or the second year. All subjects will be seen every three months. We will evaluate the following parameters every three months: 1) height, height velocity and Z-score, 2) body weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL forms specific for CF (The Cystic Fibrosis Questionnaire). After one year of study, subjects will cross-over to the other treatment arm. This 24 month study will allow us to statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple centers, and will allow us to assess sustained effect in the 20 subjects who receive GH during the first year, by comparing their results to results obtained during the year post treatment.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Human recombinant growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF patients ages 5-12 who are less than the 25th percentile for age and sex normal values for height and/or weight

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Human recombinant growth hormone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Inhibition of Aldosterone in Patients With Chronic Renal Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.

Detailed Description
-----------------
Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this. For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.

Official Title
-----------------
The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proteinuria > 500 mg/24 hours Hypertension or anti-hypertensive treatment Exclusion Criteria: Diabetic nephropathy GFR< 20 ml/min P-potassium between 3,5 mmol/l and 5,0 mmol/l

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Eplerenone | Drug: Eplerenone<br>* Once daily administration for 8 weeks and 8 weeks control.<br>|
| No Intervention: 2<br>Control | Drug: Eplerenone<br>* Once daily administration for 8 weeks and 8 weeks control.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteinuria reduction |  | bi-monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition. |  | weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Failure, Chronic, Proteinuria, Aldosterone, Renin-Angiotensin System
Clinical and Molecular Staging of Lung Cancer Stages I and IIp

Study Overview
=================
Brief Summary
-----------------
The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. In fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. The incorporation of genetic, epigenetic and proteomic information to TNM staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.In this project a prospective cohort of 320 patients with lung cancer staged I-IIp will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. Thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of TNM staging.This project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with Spanish collaborative group in lung cancer.

Official Title
-----------------
Clinical and Molecular Staging of Lung Cancer Stages I and IIp: Generation and Initial Analysis of a Clinical and Molecular Knowledge Database

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old Able to understand and sign the informed consent Exclusion Criteria: Absence of mediastinal disease

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer patients<br>Patients with lung cancer who undergo surgical resection of the tumor | Other: biomarkers<br>* This is an observational study, there is no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort creation | Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological markers | To identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, early detection
Investigating the Role of Mucin and Mucin Glycosylating Enzymes in Nasopharyngeal Carcinoma and Salivary Gland Cancer and Their Correlation With Clinical Prognosis

Study Overview
=================
Brief Summary
-----------------
Nasopharyngeal carcinoma (NPC) is the tenth leading cancers in Taiwan and investigating its biomarker is important for understanding the mechanism of its pathogenesis.

Detailed Description
-----------------
NPC is the tenth leading cancers in Taiwan and investigating its biomarker is important for understanding the mechanism of its pathogenesis.

Official Title
-----------------
Investigating the Role of Mucin and Mucin Glycosylating Enzymes in Nasopharyngeal Carcinoma and Salivary Gland Cancer and Their Correlation With Clinical Prognosis

Conditions
-----------------
Salivary Gland Cancer, Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NPC and salivary gland tumor diagnosed and treated in HTUH Exclusion Criteria: previous treatment or surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Nasopharyngeal carcinoma and salivary gland tumor<br>patients diagnosed and treated in National Taiwan University Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of expression level of mucin glycosylating enzymes (by immunohistochemistry) in nasopharyngeal carcinoma and salivary gland tissues |  | 1 5 years after patients received definite therapy | 

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