linjc16/ctgov huggingface dataset:
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

Detailed Description
-----------------
An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Official Title
-----------------
The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

Conditions
-----------------
Insomnia, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Eszopiclone (Lunesta)


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects, between the ages of 18 and 64 years inclusive Subjects with Generalized Anxiety Disorder (GAD) Subjects with insomnia related to GAD.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Active Comparator: 1<br>Escitalopram oxalate 10 mg at bedtime | Drug: Eszopiclone (Lunesta)<br>* Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime<br>* Other names: Lunesta;|
| Active Comparator: 2<br>Eszopiclone 3 mg at bedtime | Drug: Eszopiclone (Lunesta)<br>* Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime<br>* Other names: Lunesta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in subjective sleep latency averaged over the double-blind treatment period. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in subjective total sleep time averaged over the double blind treatment period. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Anxiety, Generalized Anxiety Disorder
Laparoscopic Versus Open Appendectomy

Study Overview
=================
Brief Summary
-----------------
Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.

Official Title
-----------------
Laparoscopic Versus Open Appendectomy: A Retrospective Cohort Study Assessing Outcomes and Cost-effectiveness

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Procedure: Open appendectomy
* Procedure: Laparoscopic appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute appendicitis Exclusion Criteria: Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open appendectomy<br>Subjects that underwent open surgery for appendicitis | Procedure: Open appendectomy<br> <br> |
| Active Comparator: Laparoscopic appendectomy<br>Subjects that underwent laparoscopic surgery for appendicitis | Procedure: Laparoscopic appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital cost | Mean hospital cost (in Euro) for patients that underwent appendectomy | 3 days | 
| Wound infection | Number of patients with wound infection after appendectomy | 1 week |
Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.

Official Title
-----------------
A 24-week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan/hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes elevated blood pressure and pulse pressure albuminuria Exclusion Criteria: Severe hypertension History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm Liver, kidney (not caused by diabetes), or pancreas disease Type 1 diabetes or uncontrolled type 2 diabetes Allergy to certain medications used to treat high blood pressure Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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: valsartan/hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood measures of hypertension after 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood measures of hypertension in arterial system after 24 weeks |  |  | 
| Change in protein excretion rate after 24 weeks |  |  | 
| Change in serum markers of endothelial function and oxidative stress after 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, diabetes, albuminuria, valsartan, hydrochlorothiazide, amlodipine
Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment

Study Overview
=================
Brief Summary
-----------------
Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.

Official Title
-----------------
A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Conditions
-----------------
Vitreoretinal Traction Syndrome

Intervention / Treatment
-----------------
* Drug: Plasmin
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist. Exclusion Criteria: Presence of a posterior vitreous detachment in the study eye History of vitrectomy in the study eye Proliferative diabetic retinopathy in the study eye Presence of media opacity that precludes quality examination of the vitreous and fundus.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasmin Injection<br>human-derived plasmin | Drug: Plasmin<br>* 27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.<br>|
| Placebo Comparator: Vehicle<br>Plasmin formulation, without active ingredient. | Drug: Vehicle<br>* Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a Grade A Posterior Vitreous Detachment (PVD) | PVD at the disc and macula post plamin injection | 14 Days |
A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HIP0901 capsules and Lipidilsupra tablets.

Official Title
-----------------
Open-label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics of Fenofibric Acid Between Lipidilsupra Tablet and HIP0901 Capsule in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HIP0901 / Lipidilsupra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, age between 20 and 45 Informed of the investigational nature of this study and voluntarily agree to participate in this study Weight>50kg, BMI of >18kg/m2 and <27kg/m2 subject Exclusion Criteria: Acute disease within 28 days prior to start of study drug administration Use of any prescription medication within 14 days prior to Day 1 Use of any medication within 7 days prior to Day 1 Has a severe medical history of hypersensitivity to fibric acid derivative Participation in another clinical study within 30 days prior to start of study drug administration

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIP0901<br>Fenofibric acid | Drug: HIP0901 / Lipidilsupra<br>* HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)<br>|
| Active Comparator: Lipidilsupra<br>Fenofibrate | Drug: HIP0901 / Lipidilsupra<br>* HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of Fenofibric acid |  | 0-96 hrs | 
| Cmax of Fenofibric acid |  | 0-96 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fenofibric acid, HIP0901, Lipidilsupra
Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.

Detailed Description
-----------------
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease. The study design is case-control, there are no interventions.

Official Title
-----------------
Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis

Conditions
-----------------
Psychotic Disorders

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of first episode of a psychotic disorder Healthy controls with no psychiatric disorder history Exclusion Criteria: Significant neurological or medical illness history Ages <18 or >45

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First Episode Psychosis Patients<br>Individuals experiencing a first episode of psychosis | Other: Observational<br> <br> |
| Healthy Controls<br>Psychiatrically healthy individuals | Other: Observational<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
-----------------
Schizophrenia, Schizoaffective disorder, Bipolar disorder
Cardiovascular Evaluation of Adult PHA 1 Patients

Study Overview
=================
Brief Summary
-----------------
Vascular and cardiac alterations are associated with aldosterone effects are evidenced in experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease (heart failure). The study aims at assessing vascular and cardiac alterations in adults with a chronic increase in circulating aldosterone without hypertension. The investigated population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor.

Detailed Description
-----------------
The study includes adult patients with mineralocorticoid receptor mutation as compared with not affected relatives. It includes also relatives of adult relative of patients with PHA1 in whom no mutation was found. Cardiovascular evaluation is conducted with cardiac and vascular ultrasound assessment and cardiac NMR, ambulatory blood pressure measurement. Protocol duration is 2 days . Detailed genetic study is conducted in family without identified mutation in MINERALORECEPTOR.

Official Title
-----------------
Cardiovascular Evaluation of a Rare Condition With Hyperaldosteronism Without Hypertension: PHA 1

Conditions
-----------------
Pseudohypoaldosteronism Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age over 18 Male or female gender Genotype in the PHA1.NET network Exclusion criteria: Not membership to a regime of Social Security or to a CMU Against indication in the realization of a MRI Cardiac NMR not possible Known cardiovascular disease for person not carrying MR mutation

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 |
| --- | --- |
| without PHA1<br>patients without mineralocorticoid receptor mutation | |
| PHA 1<br>patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac or vascular abnormality at ultrasound or NMR evaluation |  | day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular volume, biology, autonomic nervous system abnormality |  | day one + day two | 
| New gene responsible for PHA1 |  | day one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pseudohypoaldosteronism type 1, Mineralocorticoid receptor, Aldosterone, Cardiovascular disease
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.

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

Intervention / Treatment
-----------------
* Drug: Zoledronic acid plus EP/TP
* Drug: EP/TP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Age ≥70 years Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically or cytologically confirmed lung cancer Did not receive bisphosphonate treatment Exclusion Criteria: Appear relapse and metastasis receive other bisphosphonate treatment Active or uncontrolled infection Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Zoledronic acid plus First-line chemotherapy<br> | Drug: Zoledronic acid plus EP/TP<br>* Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression<br>|
| Active Comparator: First-line chemotherapy<br> | Drug: EP/TP<br>* Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles<br>* Other names: First-line chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS) |  | 3 years | 
| Bone mineral density(BMD) |  | 1 year | 
| Quality of life(QOL) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, patients
TIMP-2 and IGFBP7 for the Prediction of the Cardiac Surgery Associated Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.

Official Title
-----------------
Novel Biomarkers (TIMP-2 and IGFBP7) of Tubular Renal Cell Damage for the Prediction of the Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) - A Feasibility Study

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned cardiac surgery Exclusion Criteria: renal dialysis minors emergency no cardiopulmonary bypass

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 |
| --- | --- | --- |
| AKI-stadium 1 (KDIGO) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 30 days |