linjc16/ctgov huggingface dataset:
Factors Associated to Success of Hepatitis C Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Detailed Description
-----------------
Chronic hepatitis C virus(HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated three million estimated cases to 52 thousand reports. The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Official Title
-----------------
Factors Associated to Success of Hepatitis C Therapy

Conditions
-----------------
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted

Intervention / Treatment
-----------------
* Drug: pegylated-interferon, conventional-interferon, ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HVC patients that received specific treatment with pegylated-interferon or conventional-interferon, and ribavirin Exclusion Criteria: No HVC infection or treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| HVC Patients<br>HVC patients attended in SAE e HD. | Drug: pegylated-interferon, conventional-interferon, ribavirin<br>* Genotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks.<br>* Other names: Ribavirin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors

Study Overview
=================
Brief Summary
-----------------
To investigate the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors in China

Detailed Description
-----------------
Patients who were successfully prescribed with orthokeratology lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine were enrolled in the study. Our study used two different methods to collect data. For complications and effect of orthokeratology information, data were collected by a retrospective survey. A questionnaire was used to collect influencing factors of safety and effect of orthokeratology.

Official Title
-----------------
Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were successfully prescribed with ortho-k lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine Exclusion Criteria: Patients who have ceased wearing orthokeratology or who were using other methods of myopia control

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length | changes in axial length | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthokeratology, myopia control
An Investigational Drug Study in Obese (Considerably Overweight) Patients (0364-006)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with obesity (considerably overweight).

Official Title
-----------------
A Study to Assess the Safety and Efficacy of MK0364 in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: MK0364


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are obese (considerably overweight) based on body mass index. Exclusion Criteria: Patients with serious or unstable current or past medical conditions

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: MK0364|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
-----------------
Obesity and obesity-related medical conditions
Safety of the PET-511BTM Transesophageal Transducer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the redesigned transesophageal echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through the mouth.

Detailed Description
-----------------
The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall. The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.

Official Title
-----------------
Safety of the PET-511BTM Transesophageal Transducer (TEE)

Conditions
-----------------
Patient Requiring TEE Procedure by Their Physician

Intervention / Treatment
-----------------
* Device: PET-511BTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients between the ages of 20 and 80 Informed consent understood and signed Compliance with post-treatment follow-up protocol requirements Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| TEE Procedure<br>Patients who have been scheduled for a TEE procedure by their physician | Device: PET-511BTM<br>* Transesophageal Transducer<br>* Other names: TEE Probe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The TEE transducer passes safely into the esophagus. |  | during, 30 minutes, and 24 hours after the exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TEE, transesophageal, transducer
Evaluation of QoL, Tolerability and Use of Zoladex 10,8 SafeSystem for Advanced PCa - German IPEP Trial

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is the evaluation of QoL, tolerability and use of Zoladex 10,8 SafeSystem for advanced PCa under naturalistic conditions

Official Title
-----------------
Quality Assurance Project in Patients With Advanced Prostate Carcinoma - Evaluation of Tolerability, Quality of Life and Usage of Zoladex 10,8 SafeSystem

Conditions
-----------------
Prostate Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PCa, who will be treated with Zoladex 10,8 SafeSystem based on the current SPC
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate carcinoma, LHRH, Zoladex
Therapeutic Recommendations for Nephroblastoma

Study Overview
=================
Brief Summary
-----------------
The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.

Detailed Description
-----------------
The study is based on results form 2 previous studies carried out by the GFAOP. This study aims to evaluate the capacity of units to follow the recommendations in the protocol. It will look mainly at treatment compliance and outcome for the children treated. The study will also evaluate the improvement in treatment compliance and reporting. This work will help the group to evaluate future needs in participating units and help us adapt treatment programmes to local conditions.

Official Title
-----------------
Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.

Conditions
-----------------
Nephroblastoma

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment. . Exclusion Criteria: Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 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 |
| --- | --- |
| Children with Nephroblastoma<br>All children coming into the participating units with suspected Nephroblastoma. | Other: Data collection<br>* Clinical stage, treatment given and observations of toxicity if any, outcome following treatment and follow up.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the number of cases with local disease. | By evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis. | 5 years | 
| Evaluation of the number of cases with stage IV disease. | By evaluating the initial clinical reports and later histological reports to confirm the stage. | 5 Years | 
| Evaluating the treatment given. | Comparison of treatment given and recommended treatment. | 5 Years | 
| Evaluating the follow up after treatment. | How many children alive or dead after treatment | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Why has treatment failed | look at precision of reporting by comparing reports (histological and surgical) | 5 years |
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)

Study Overview
=================
Brief Summary
-----------------
This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis

Official Title
-----------------
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)

Conditions
-----------------
Scalp Psoriasis

Intervention / Treatment
-----------------
* Drug: Xamiol® Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway Exclusion Criteria: Contraindications of Xamiol® Gel listed in the German package insert Pretreatment with Xamiol® within the last 4 weeks Systemic treatment of psoriasis UV light 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xamiol® Gel|Once daily application for about 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment of scalp psoriasis |  | After approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Quality of Life |  | After approximately 4 weeks |
Evaluation of PK and Safety of D-0120 and Allopurinol

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects

Official Title
-----------------
A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: D-0120 in combination with Allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects between the ages of 18-55 Required evaluation by Investigator for screening and enrollment Agreement and compliance with the study and follow-up procedures Exclusion Criteria: Significant medical history or current comorbidly determined by the Investigator. Pregnant or nursing women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: D0120 Allopurinol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-0120 plus Allopurinol<br>D-0120 dosing followed by Allopurinol and combination treatment | Drug: D-0120 in combination with Allopurinol<br>* noted above<br>|
| Experimental: Allopurinol plus D-0120<br>Allopurinol dosing followed by D-0120 and combination treatment | Drug: D-0120 in combination with Allopurinol<br>* noted above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, incidence, severity and attribution of AEs. | Evaluation of safety between D-0120 and Allopurinol | 14 days | 
| Plasma concentration of D-0120 and Allopurinol | Evaluation of exposure between D-0120 and Allopurinol | 14 days |
The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).

Official Title
-----------------
The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age at enrollment Confirmed diagnosed with RA Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site Exclusion Criteria: Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels Was followed at the site for less than 1 year since biologic treatment initiation Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| RA patients treated with Abatacept<br>Treated with Abatacept as a first-line biologic | Other: Non-interventional<br>* Non-interventional<br>|
| RA patients treated with TNFi<br>Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic | Other: Non-interventional<br>* Non-interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients discontinuing treatment before completing 12 months of therapy |  | approximately 1 year | 
| time from treatment initiation to discontinuation |  | approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Healthcare Resource Utilization (HCRU) |  | approximately 1 year | 
| Disease Activity Score | Disease Activity Score (DAS) | approximately 1 year | 
| Health Assessment Questionnaire | Health Assessment Questionnaire (HAQ) | approximately 1 year | 
| C-reactive Protein Levels | C-reactive protein (CRP) levels | approximately 1 year | 
| Erythrocyte Sedimentation Rate | Erythrocyte sedimentation rate (ESR) levels | approximately 1 year | 
| Joint Erosions | Measured by radiographic reports | approximately 1 year |
Early Feeding Versus Conventional Feeding

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are: • whether it is beneficial to start oral feeding within 12hrs after stoma reversal Participants will be randomly assigned two groups either early feeding or conventional group

Official Title
-----------------
Effectiveness of Early Feeding Versus Conventional Feeding After Stoma Reversal in Adult Surgical Surgical Practices

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: early feeding
* Procedure: conventional feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having ileostomy no peritonitis intestinal obstruction Exclusion Criteria: uncontrolled diabetes uncontrolled hypertension sepsis

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early feeding group<br>after stoma reversal in patients in this group oral feeding was started with in 12 hrs after surgery | Other: early feeding<br>* oral feeding within 12hours after stoma reversal<br>|
| Active Comparator: conventional feeding group<br>after stoma reversal in patients in this group oral feeding was started 48hrs after surgery | Procedure: conventional feeding<br>* oral feeding after 48hours of NBM after stoma reversal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus | comparison of post-op anastomotic leakage hospital stay wound infection | 5days |
Postural Control Among Children With and Without Dyslexia

Study Overview
=================
Brief Summary
-----------------
As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on the static balance between dyslexic and non-dyslexic children using the Chinese language.

Official Title
-----------------
The Influence of Visual Information on Postural Control Among Children With and Without Dyslexia

Conditions
-----------------
Child Development Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Normal IQ(>85, WISC-III) 2.Children with dyslexia assessed by standard tools, performed by psychological-teachers of special education Exclusion Criteria: 1.Attention deficit hyperactivity disorder(ADHD) 2.Neurological or psychiatric abnormalities 3.Developmental coordination disorder(DCD)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 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 |
| --- | --- |
| Children with dyslexia<br> | |
| Non-dyslexic children<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural sway analysis | Root mean squared sway amplitude and sample entropy along the AP and ML axes | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stabilogram diffusion analysis of central of pressure | Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child with dyslexia, postural sway, visual perception