linjc16/ctgov huggingface dataset:
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.

Official Title
-----------------
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White

Conditions
-----------------
Vascular Dementia, Stroke

Intervention / Treatment
-----------------
* Drug: Cilostazol
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ranging from 40 to 80 years After newly ischemic stroke from 3 months to 2 years Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)>=4 Moderate or mild cognitive deficits: MMSE 12-26 Vascular or mixed dementia: Hachinski ischemic score>4 Moderate or mild disability: MRS<=4,NIHSS<20 Informed consent Exclusion Criteria: Definitive diagnosis of dementia prior to the stroke Cerebral hemorrhage in the past Cerebral embolism result from cardiogenic embolus Critically ills: MRS>4,NIHSS>=20 Bed-ridden patient who is hardly discovered newly stroke patient with sever cardiac, hepatic or nephric complication dementia caused not by vascular lesions other diseases disturb the cognitive evaluation susceptibility to varieties of allergen abstain from Cilostazol or Asprin antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases rejected to participate by the patient or the family

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cilostazol | Drug: Cilostazol<br>* Cilostazol 100 mg bid for 12 months<br>|
| Active Comparator: 2<br>Asprin | Drug: Aspirin<br>* Aspirin 100 mg qd for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke recurrence, other vascular ischemic events, bleeding events |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition
Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

Detailed Description
-----------------
Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images. The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

Official Title
-----------------
Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Device: Tomo Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman over 40 years of age Has a tomosynthesis examination with comparator Has a mammographic finding Exclusion Criteria: Pregnant, breastfeeding or believes she may be pregnant Unable or unwilling to give informed consent

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tomo Assessment<br>Subjects will have a 4-view tomosynthesis examination with the study device. | Device: Tomo Assessment<br>* A four-view tomosynthesis examination<br>* Other names: MicroDose Tomosynthesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray dose | X-ray dose will be measured per projection. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion conspicuity comparison of images from study device vs comparator | Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator | 4 months |
Co-culture and Advanced Maternal Age in PGS Program

Study Overview
=================
Brief Summary
-----------------
Fertilization and embryo development in vivo occurs in appropriate conditions in the mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations that may affect embryo development and viability in vitro. In Preimplantation Genetic Screening program (PGS) the investigators need to culture the embryos until day 5 so the requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As it has been shown before, embryo culture conditions have the potential to impact biopsied embryos and hence PGS success rates. Nowadays the coculture system with endometrial cells could be an alternative option to improve the blastocyst rates since some publications have indicated that endometrial cells may provide trace elements and growth factors that are not present in defined culture media and reproduce physiologic conditions. Although the role of coculture in vitro fertilization (IVF) has been controversial, a recent meta-analysis has established the potential benefits of coculture system. The aim of this study was to compare embryologic and clinical outcomes in terms of blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC) coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS program.

Official Title
-----------------
Co-culture Versus Sequential Culture System in Advanced Maternal Age.

Conditions
-----------------
Age Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced maternal age (>39) undergoing PGS cycle Exclusion Criteria: Other PGS indication Altered karyotype

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 47 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>sequential culture system | |
| Co-culture system<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | from February 2009 to December 2010 |
Assessment of the Effectiveness of Menopur in Intrauterine Insemination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.

Official Title
-----------------
Assessment of the Clinical Efficacy of Menopur® in Intrauterine Artificial Insemination (From Partner or From Donor)

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: hMG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI Seminal sample suitable for artificial insemination treatment according to the criterion of each centre Patient prescribed therapy with Menopur in artificial insemination Exclusion Criteria: Contraindications to intrauterine insemination Contraindications to Menopur
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hMG<br> | Drug: hMG<br>* Patients with a condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 40 weeks |
A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.

Official Title
-----------------
A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer, Non-small-cell Lung Carcinoma

Intervention / Treatment
-----------------
* Drug: Tarceva (erlotinib HCl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written (signed) informed consent(s) Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients) Age >=18 years ECOG performance status of 0 to 3 Recovered from the toxic effects of prior therapy Able to comply with study and follow-up procedures Able to take oral medication Use of an effective means of contraception (for patients with reproductive potential) Granulocyte count >=1.0 x 10^9/L Platelet count >=75 x 10^9/L Serum bilirubin <1.5 x upper limit of normal (ULN) SGOT (AST) <2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be <5 x ULN Serum creatinine <=1.5 mg/dL Exclusion Criteria: Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease) Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90% Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable Nursing mothers or pregnant females

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tarceva (erlotinib HCl)|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced non-small cell lung cancer
Three-Year Follow-up of Radioiodine Therapy for Goitre

Study Overview
=================
Brief Summary
-----------------
Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction. Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine therapy outcome in MNG patients. Design: This was a long-term (36 months) observational study. Methods: The investigators measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80 years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection. Urinary iodine was measured at baseline and at 3 months after following a low iodine diet. TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48 h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume was assessed by computer tomography at baseline and every 6 months thereafter.

Official Title
-----------------
Long-Term Follow-up and Outcome of Administering Recombinant Human Thyrotropin as an Adjuvant of Therapy With Radioiodine in the Outpatient Treatment of Multinodular Goitres

Conditions
-----------------
Tratment of Multinodular Goitre

Intervention / Treatment
-----------------
* Radiation: Radioactive iodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multinodular goitre Exclusion Criteria: Aversion to any form of treatment Previous radioiodine therapy Being unable to complete a prolonged follow-up; and Having serious cardiovascular disorders.

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Radiation: Radioactive iodine|Radioactive iodine preceded by rhTSH|

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
-----------------
multinodular, goitre, recombinant human TSH
International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

Detailed Description
-----------------
In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area. To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.

Official Title
-----------------
International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

Conditions
-----------------
Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven colon adenocarcinoma Pathological stage Ⅰ, Ⅱ or Ⅲ Potentially curative surgery Informed consent for observational data collection Exclusion Criteria: Tis (mucosal cancer) Multiple colon cancers All patients with preoperative adjuvant therapy
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 |
| --- | --- | --- |
| Distribution of metastatic LNs |  | At the time of patient registry in | 
| Distribution of metastatic LNs |  | At the time of 4 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic outcomes according to the length of bowel resection |  | 4 years | 
| Prognostic outcomes according to the central radicality |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon cancer, lymph node, extent of bowel resection
Real-time Continuous Cardiac Output Measurements

Study Overview
=================
Brief Summary
-----------------
Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Detailed Description
-----------------
Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE) Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements Study design: prospective, feasibility study Study population: Adult Intensive Care patients ( > 18 years) Intervention (if applicable): Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements. Main study parameters/endpoints: Percentage of patients in which continuous cardiac output can be measured using TTE Correlation between continuous TTE and Flotrac measurements

Official Title
-----------------
Real-time Automatic Continuous Cardiac Output Measurements Using Transthoracic Echocardiography (TTE) in ICU-patients in Comparison to Flotrac Measurements

Conditions
-----------------
Cardiac Output, Low

Intervention / Treatment
-----------------
* Device: TTE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Intensive Care patients ( > 18 years) Exclusion Criteria: Pregnancy Atrial fibrillation or other irregular heart rhythm

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac output measurements<br>Cardiac output will be measured using TTE continuously with ProbeFix | Device: TTE<br>* Transthoracic echocardiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in which the ProbeFix can be used continuously | Percentages will be reported | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between continuous TTE and Flotrac | Bland-Altman plot will be reported | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac output, TTE
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled study.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Venlafaxine ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatient 8-17 year old diagnosis of Social Anxiety Disorder Exclusion Criteria: concomitant psychiatric or medical disorders which interfere with safety or assessment

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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: Venlafaxine ER|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response, defined as a score of 1 (very much improved) or (very improved), on the Clinical Global Impressions-Improvement (CGI-I) scale; Final on therapy Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-AC) total score. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Anxiety, Children Disorders