linjc16/ctgov huggingface dataset:
Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

Study Overview
=================
Brief Summary
-----------------
A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.

Official Title
-----------------
Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

Conditions
-----------------
Hepatocellular Carcinoma, Portal Vein Thrombosis, Hepatic Portal Vein Tumor Invasion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection, with or without hepatic cirrhosis association; presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels; Exclusion Criteria: Patients undergoing prior systemic treatment; Patients presenting incomplete data that do not allow their classification according to the stratification models; Patients whose information of progression or death can not be recovered;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular carcinoma underwent surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis (disease graduation) | The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis. | 1 to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate in years | Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy. | 1 to 3 years | 
| Relation established between survival and degree of underlying liver dysfunction | Investigate a possible relationship between survival and degree of underlying liver dysfunction in patients with thrombosis or portal vein invasion in patients undergoing curative hepatectomy. | 1 to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Thrombosis, Portal Vein Invasion
Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

Study Overview
=================
Brief Summary
-----------------
This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.

Official Title
-----------------
Local Anesthetics New Formulations: From Development to Clinical Tests

Conditions
-----------------
Dental Anesthesia Efficacy

Intervention / Treatment
-----------------
* Drug: Prilocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good health no history of allergy to the components of the local anesthetic formulations tested maxillary canine, lateral incisor, and first premolar responsible to electric stimulation Exclusion Criteria: intake of any medication that would alter pain perception history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liposome-encapsulated 3% prilocaine<br> | Drug: Prilocaine<br>* 1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine<br>* Other names: Citocaína®;|
| Active Comparator: 3% plain prilocaine<br> | Drug: Prilocaine<br>* 1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine<br>* Other names: Citocaína®;|
| Active Comparator: 3% prilocaine with 0,03IU/mL felypressin<br> | Drug: Prilocaine<br>* 1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine<br>* Other names: Citocaína®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia success, onset and duration of pulpal and gingival anesthesia. |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection pain - Visual Analogue Scale |  | 1 minute after the injections | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liposome, Prilocaine, Dental anesthesia
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to provide written informed consent before beginning any study related procedures Patient has a documented clinical diagnosis of major depressive disorder Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: Patients with a history of non-compliance as judged by the study investigator Patients with a known lack of response to previous treatment with quetiapine Patients who have participated in a clinical trial within 4 weeks of randomization

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo |  |  | 
| To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Depression
Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.

Official Title
-----------------
Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of early stage idiopathic Parkinson's Disease No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d Exclusion Criteria: Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic PD patients<br> | Drug: Pramipexole<br> <br> * Other names: Sifrol®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dosing details of Pramipexole |  | up to 21 months | 
| Occurrence and clinical course of Parkinson Disease (PD) motor symptoms |  | up to 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Kinetic Tremor | Spiral test with at least five rotations from the centre to the edge in blinded fashion | up to 21 months | 
| Change in dosing details of L-Dopa |  | up to 21 months | 
| Global Assessment of tolerability by investigator on 4-point scale |  | after 21 months | 
| Global assessment of efficacy by investigator on a 4-point scale |  | after 21 months | 
| Number of patients with adverse drug reactions |  | up to 21 months |
Follow-up Study to Investigate Long Term Effect of Supplementing Pre- and Probiotics in Children Born by C-Section

Study Overview
=================
Brief Summary
-----------------
This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.

Detailed Description
-----------------
This is an extension of investigation on the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section from an earlier completed study.

Official Title
-----------------
A Follow-up Clinical Study to Investigate the Long Term Effect of Supplementation of Pre- and Probiotics in Early Life in Children Born by Caesarean Section (Julius SN Follow-up 1)

Conditions
-----------------
Caesarean Section Born Children

Intervention / Treatment
-----------------
* Other: Prebiotics
* Other: Prebiotics & Probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the Julius SN study until 16 weeks of age Written informed consent from parent(s) or legally acceptable representatives Exclusion Criteria: Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 54 Months

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 |
| --- | --- |
| Prebiotics group<br>No intervention since is a follow-up study | Other: Prebiotics<br>* To study the long term effect of supplementation in early life<br>|
| Prebiotics & Probiotics group<br>No intervention since is a follow-up study | Other: Prebiotics & Probiotics<br>* To study the long term effect of supplementation in early life<br>|
| Control group<br>No intervention since is a follow-up study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute count of Bifidobacterium | Difference in absolute count of bifidobacterium between study groups | 3 - 4 years old | 
| Absolute level of fecal lactate | Difference in absolute level of fecal lactate between study groups | 3 - 4 years old | 
| Incidence of allergy manifestation | Difference in parent-reported cumulative incidences of allergy manifestation between study groups | 3 - 4 years old | 
| Incidence of gastrointestinal symptoms | Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups | 3 - 4 years old | 
| Incidence of infection | Difference in parent-reported cumulative incidences of infection between study groups | 3 - 4 years old |
Lipid Peroxidation in Workers Exposed to Al,Ga,In,As,and Sb in Optoelectronic Industry

Study Overview
=================
Brief Summary
-----------------
To investigate whether exposure to Al, Ga, In, As, and Sb induces lipid peroxidation in humans. Whole blood and urine levels of 170 workers were analysed by use of ICP-MS. MDA, the product of lipid peroxidation was determined by HPLC

Detailed Description
-----------------
If MDA as an index of lipid peroxidation can be induced by these metals. We will suggest reducing exposure to these metals

Conditions
-----------------
Urine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Optoelectronic workers Exclusion Criteria: Office workers

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 45 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malondialdehyde optoelectronic vitamin complex
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.

Official Title
-----------------
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Bosutinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults

Conditions
-----------------
Breast Cancer, Leukemia, Myeloid, Chronic

Intervention / Treatment
-----------------
* Drug: Bosutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria (for both study populations): Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone [FSH] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after test article administration. Have a high probability for compliance with and completion of the study. Exclusion criteria (for both study populations): History of clinically important cardiovascular disease. Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death. Presence or history of any disorder that may prevent the successful completion of the study. Other inclusion and exclusion criteria apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Bosutinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. |  | 5 weeks |
Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA

Study Overview
=================
Brief Summary
-----------------
Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.

Detailed Description
-----------------
a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.

Official Title
-----------------
Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial

Conditions
-----------------
Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine injection
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II Age 6 to 12 years Any gender Exclusion Criteria: ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midazola.<br>Inj.midazolam | Drug: Midazolam<br>* Inj.midazolam 5mg/5ml given in stat doses<br>|
| Experimental: Dexnedetomidine<br>inj.dexmedetomidine | Drug: Dexmedetomidine injection<br>* Inj precedex 200mcg in 1ml given in stat doses<br>* Other names: Precidex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dexmedetomidine is better sedative agent than midazolam in pediatric population |  | 25 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Midazolam is better sedating agent than dexmedetomidine in pediatric population |  | 25 minutes | 
| Midazolam and dexmedetomidine are equally good sedating agents in pediatric population |  | 25 minutes |
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berodual®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease Only patients which have not been treated with Berodual® within the last year should be included Exclusion Criteria: Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| chronic obstructive respiratory tract disease patients<br> | Drug: Berodual®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall severity of the clinical picture rated on a 4- point scale |  | after 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of efficacy by patient on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of tolerability by investigator on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of tolerability by patient on a 4-point scale |  | after 3 and 6 weeks | 
| Number of patients with adverse drug reactions |  | up to 6 weeks |