linjc16/ctgov huggingface dataset:
Impact of Oral Diets on Postoperative Fluid Collection

Study Overview
=================
Brief Summary
-----------------
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Detailed Description
-----------------
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.

Official Title
-----------------
Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Dietary Supplement: Immunonutrition
* Dietary Supplement: High-protein nutrition
* Dietary Supplement: Standard nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed breast cancer or melanoma scheduled surgery with axillary lymph nodes resection informed consent eligible for surgery Exclusion Criteria: benign disease no consent

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
Interventional Model Description: 4 arm randomized study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunonutrition<br>Oral immunonutrition containing arginine, omega-PUFAs and antioxidants | Dietary Supplement: Immunonutrition<br>* Oral immunonutrition containing arginine, omega-PUFAs and antioxidants<br>|
| Active Comparator: High-protein diet<br>Oral nutrition with high-protein content | Dietary Supplement: High-protein nutrition<br>* Oral nutrition with high-protein content<br>|
| Active Comparator: Standard nutrition<br>Oral nutrition with standard ingredients | Dietary Supplement: Standard nutrition<br>* Oral nutrition with standard ingredients<br>|
| No Intervention: No intervention<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid collection | The volume of fluid collection after lymph nodes resection expressed in mililiters | 6 months |
Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Rivoglitazone
* Drug: Pioglitazone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes in male or female patients Between 18 and 75 years of age With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization Exclusion Criteria: Type 1 diabetics or type 2 diabetics currently on insulin therapy Patients unwilling or unable to discontinue their anti-diabetic medication(s) History of ketoacidosis History of therapy with rosiglitazone, troglitazone, pioglitazone

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

| Intervention/Treatment |
| --- |
|Drug: Rivoglitazone|nan|
|Drug: Pioglitazone|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG, Lipids, hsCRP, Adiponectin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Placebo and active control dose response study of rivoglitazone in type 2 diabetics
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of intravitreal Aflibercept (IVA) injection therapy, combined with peripheral laser photocoagulation, in the treatment of macular edema caused by Leber's miliary aneurysm. We believe that our study makes a significant contribution to the literature because to our knowledge, it is the first to report cases, in which IVA injection therapy was used to treat this condition.

Official Title
-----------------
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation

Conditions
-----------------
Macular Edema Caused by Leber's Miliary Aneurysms

Intervention / Treatment
-----------------
* Other: Panretinal photocoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FA revealed many aneurysms with leakage in the temporal mid-peripheral retina and near the macula. Optical coherence tomography (OCT) showed moderate to marked cystoid macular edema and subretinal fluid. There were no abnormal findings in the cornea, anterior chamber, or lens. No particular lesions were found in the opposite eye of each subject. Based on these findings, the patients were diagnosed with Leber's miliary aneurysm. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 14 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: all patients in the study<br> | Other: Panretinal photocoagulation<br>* Intravitreal Aflibercept with PRP to the peripheral vascular lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity improvement |  | 6 months after 3 consequative injections |
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients Wtih Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in the treatment of glaucoma or ocular hypertension

Conditions
-----------------
Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost/timolol fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient needs IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist therapy

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

| Intervention/Treatment |
| --- |
|Drug: bimatoprost/timolol fixed combination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  |  |
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions

Study Overview
=================
Brief Summary
-----------------
to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

Detailed Description
-----------------
The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.

Official Title
-----------------
Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.

Conditions
-----------------
White Spot Lesion of Tooth

Intervention / Treatment
-----------------
* Other: pearl powder
* Drug: CPP-ACP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good oral hygiene cooperative patient completion of orthodontic therapy presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment Exclusion Criteria: bad oral hygiene lack of patients compliance allergy to milk products pregnant or lactating women presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth presence of periodontal pockets around maxillary anterior teeth

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pearl powder<br>natural product, support bone and joint health | Other: pearl powder<br>* natural product, support bone and joint health<br>|
| Active Comparator: CPP-ACP<br>product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces. | Drug: CPP-ACP<br>* Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate<br>* Other names: tooth mousse;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries prevention in enamel white spot lesion | caries prevention using laser fluorescence device | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
white spot lesions,, pearl powder, CPP-ACP
OCTA in Epivascular Glia After Dex Implant

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study was for the first time, to analyze specific morphologic features in diabetic eyes with macular oedema, such as changes of the foveal avascular zone and the presence of epivascular glia, and see how they would change after dexamethasone intravitreal implant

Official Title
-----------------
Evaluation of Changes in Epivascular Glia Before and After Intravitreal Dexamethasone Implant : an OCT Pilot Study

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Dexamethasone intravitreal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic retinopathy complicated by macular edema Exclusion Criteria: congenital eye disorders, previous diagnosis of other ocular diseases history of vitreous hemorrhage

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with diabetic macular edema<br> | Drug: Dexamethasone intravitreal implant<br>* Dexamethasone intravitreal implant<br>|
| healthy patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in epivascular glia after Dexamethasone implant in patients with diabetic retinopathy and inflammatory macular edema |  | up to 6 months |
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

Detailed Description
-----------------
Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short information centered psychoeducation (ICP) of 8 sessions or a cognitive behavioral treatment (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms. The primary endpoint is relapse at the one and two year follow up.

Official Title
-----------------
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

Conditions
-----------------
Schizophrenic Disorders

Intervention / Treatment
-----------------
* Behavioral: cognitive behavioural therapy
* Behavioral: psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenic disorder according to ICD 10: F20 first episode age between 18 and 55 willingness to give informed consent also to a double blind pharmacological treatment study Exclusion Criteria: residence outside of the catchment area insufficient knowledge of the German language substance abuse or addiction as primary clinical problem serious physical illness organic brain disease pregnancy contraindications to neuroleptic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- |
|Behavioral: cognitive behavioural therapy|nan|
|Behavioral: psychoeducation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative measures of symptoms |  |  | 
| social functioning |  |  | 
| cognitive functioning |  |  | 
| quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

Study Overview
=================
Brief Summary
-----------------
First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.

Official Title
-----------------
Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced lung disease qualification for lung transplantation written informed consent pulmonary capillary wedge pressure < 15 mmHg Exclusion Criteria: cancer, history of idiopathic pulmonary hypertension, primary valvular heart diseases, coronary artery disease, collagen vascular disease, history or evidence of left ventricular dysfunction, atrial fibrillation, increased liver enzyme levels ( 3 times the upper laboratory limit), renal dysfunction (estimated glomerular filtration rate < 60 ml/min/1.73m2) patients who didn't write the personal informed consent any specific therapy for PH.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mPAP ≥ 25 mmHg<br>mean pulmonary artery pressure (mPAP) ≥ 25 mmHg (37 patients) | |
| mPAP < 25 mmHg<br>mean pulmonary artery pressure (mPAP) < 25 mmHg (28 patients). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after the initial right heart catheterization (RHC) measurements |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Echocardiography, Lung Transplantation
Genetics of Uveitis

Study Overview
=================
Brief Summary
-----------------
In order to improve the investigators knowledge about uveitis and the underlying mechanism of disease, the investigators propose collecting blood from patients with uveitis, isolating DNA and sequencing the DNA to identify genetic mutations or associations in these patients.

Official Title
-----------------
Genetics of Uveitis

Conditions
-----------------
Uveitis, Infectious Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient above with the diagnosis of uveitis. Any patient with a diagnosis of infectious uveitis such as toxoplasmosis retinochoroiditis, herpes associated retinitis. Exclusion Criteria: Patients who are unable to give consent Patients in whom an adequated blood sample can not be obtained.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Uveitis<br>Uveitis or infectious uveitis patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non infectious uveitis | Distinct uveitis conditions will have a polymorphism association or specific mutation. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious uveitis | Infectious uveitis (such as herpes associated uveitis, toxoplasmosis retinochoroiditis) will have specific polymorphisms/mutations in innate immune system genes which predispose the patient to infectious uveitis. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Infectious
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)

Study Overview
=================
Brief Summary
-----------------
This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.

Detailed Description
-----------------
The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.

Conditions
-----------------
Stable Angina, Unstable Angina

Intervention / Treatment
-----------------
* Procedure: Paclitaxel-coated Balloon
* Device: Paclitaxel-eluting Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent >18y Stable Angina or Unstable Angina Single restenotic lesion in a previously stented coronary artery Exclusion Criteria: Acute Myocardial Infarction within 72h Serum Creatinine>2.0 mg/dL Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel Contraindications to contrast media Life expectancy < 2y Target Lesion length > 30mm Target Lesion diameter <= 2.5 mm Target stenosis < 70% Massive Calcifications in the target segment Evidence of intra-coronary thrombus

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel-coated Balloon<br>Paclitaxel-coated Balloon Angioplasty | Procedure: Paclitaxel-coated Balloon<br>* POBA<br>* Other names: Orbus;|
| Active Comparator: Paclitaxel-eluting Stent<br>Paclitaxel-eluting Stent Implantation | Device: Paclitaxel-eluting Stent<br>* Stenting<br>* Other names: Taxus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis defined as >50% diameter stenosis by QCA |  | 6 months | 
| Major Adverse Cardiac Events |  | 6, 12 months | 
| Target Lesion Revascularization |  | 6, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restenosis, POBA, Stenting, Paclitaxel