linjc16/ctgov huggingface dataset:
Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Detailed Description
-----------------
Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease. By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Official Title
-----------------
Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

Conditions
-----------------
Hepatitis B, Hepatocellular Carcinoma, Chronic Liver Disease

Intervention / Treatment
-----------------
* Genetic: Polymorphism of IL-1 beta and TNF-alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg-positive patients Exclusion Criteria: HBsAg-negative patients
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cytokines were determined<br>prevalence of genetic polymorphisms of interleukin 1B was measured in HBV-related hepatocellular carcinoma | Genetic: Polymorphism of IL-1 beta and TNF-alpha<br>* To analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma<br>* Other names: interleukin-1L;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine polymorphisms increase risk for hepatocellular carcinoma |  | years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokine gene, hepatitis B, hepatocellular carcinoma, chronic liver disease
Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Study Overview
=================
Brief Summary
-----------------
The investigators are comparing post-operative patient-rated functional outcome between patients who undergo corrective osteotomy for extra-articular malunited distal radius fractures with and without computer assisted pre-operative planning and virtual osteotomy.

Official Title
-----------------
Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Conditions
-----------------
Extra-articular Distal Radius Malunions

Intervention / Treatment
-----------------
* Procedure: Corrective osteotomy with computer-assisted pre-operative planning
* Procedure: Corrective osteotomy with conventional preoperative planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (over 18 yrs of age) Extra-articular malunion of the distal radius Fluent in English Exclusion Criteria: Pregnant patients prisoners patients with impaired decision making ability patients with a bony deformity in the distal forearm contralateral to the one with distal radius malunion

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Computer-assisted pre-operative planning<br>Patients enrolled in this arm will undergo corrective surgery of the distal radius, with pre-operative computer-assisted planning and virtual osteotomy. | Procedure: Corrective osteotomy with computer-assisted pre-operative planning<br>* The corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy.<br>|
| Active Comparator: Conventional pre-operative planning<br>Patients in this group will undergo corrective osteotomy of the distal radius wit conventional pre-operative planning. | Procedure: Corrective osteotomy with conventional preoperative planning<br>* The corrective osteotomy will be planned with conventional preoperative planning.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength | Grip strength as compared to the normal, contralateral hand is considered the most important outcome measure for patients with distal radius fractures. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion |  | Up to 12 months | 
| DASH Questionnaire |  | Up to 12 months | 
| Mayo Wrist score |  | Up to 12 months | 
| Gartland and Werley score |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal radius malunion, extra-articular
Control of Center of Mass to Predict Balance Ability and Fall Risks in Elderly

Study Overview
=================
Brief Summary
-----------------
Falling among older adults is a major public health concern. In fact, falls are the leading cause of accidental death in older adults both in Taiwan and in the United States. In order to provide effective preventative strategies, the investigators must understand the mechanisms that cause older adults to fall. Thus, the investigators research aim for three objectives: (1) using biomechanical model to identify the deficits in neuromuscular control for older adults (2) to apply research findings to the development of new clinical methods for assessing and recovering balance control in older adults, and (3) to predict fall risks in 1-2 year for older adults from the research findings.

Official Title
-----------------
Analysis of Muscle Strength and Control of Center of Mass Acceleration Mechanism to Predict Balance Ability and Fall Risks in Elderly

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: can stand for 5 minutes without support with normal or corrected to normal vision age between 20-35 years old for young adults group, and 65-80 years old for older adults group had fall history in the past 3 years for the older adults group. Exclusion Criteria: pregnant women with cancer diagnosis with sensory-motor deficits with osteoporosis for older adults group (T-score below -2.5)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Healthy older people over 65 years old
Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Study Overview
=================
Brief Summary
-----------------
Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Detailed Description
-----------------
Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major. Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.

Official Title
-----------------
Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Conditions
-----------------
Nigella Sativa With Beta Thalassemia Major

Intervention / Treatment
-----------------
* Drug: nigella sativ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thalassemia with iron overload Exclusion Criteria: Thalassemia complicated with diabetes mellitus or hepatitis Patients who discontinue treatment

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients receiving Nigella<br>40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months. | Drug: nigella sativ<br>* nigella sativa powder (2 gm/day) for 3 consecutive months.<br>|
| No Intervention: patients not received nigella as controls<br>40 patients in the control group will not receive nigella sativa and continued on the usual chelators | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malondialdehyde | nmol serum level of malondialdehyde (nmol per liter) | 3 months | 
| cluster of differentation4 and 8(CD4 and CD8) | CD4 and CD8 cell per cmm | 3 months | 
| total antioxidant | total antioxidant(mmol per liter) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum iron | microgram per dl | 3 months | 
| total iron binding capacity | microgram per dl | 3 months | 
| serum ferritin | ng per ml | 3 months | 
| complete blood count | complete blood count | 3 months |
Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia

Official Title
-----------------
Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule

Conditions
-----------------
Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child aged 1 to 18 years Child with hematology or cancer Child with a febrile neutropenia post-chemotherapy Child with social security No opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor. Exclusion Criteria: Febrile neutropenia at diagnosis of tumor disease Child with palliative care Child having had a hematopoietic stem cell allo-graft in the preceding year Febrile neutropenia immediately post auto-transplant Antibiotherapy prior to admission Initial care in a non-investigative center.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- | --- |
| Blood culture | Presence or not of bacteriemia | On average between 5 days and 1 month | 
| Positive bacterial culture from a normally sterile site | Presence or not of bacterial infection | on average between 5 days and 1 month | 
| microbiological culture | Presence or not of focal infection at high risk of dissemination was defined as any local infection with or without microbiological documentation into a normally sterile site, with significant risk of loco-regional or systemic spread | On average between 5 days and 1 month | 
| Fungal culture | Presence or not of fungal infection is referred to a proven, probable, or possible fungal infection as defined by the IFICG ot the EORTC | On average between 5 days and 1 month |
Photodynamic Therapy With Verteporfin for Corneal Neovascularization

Study Overview
=================
Brief Summary
-----------------
Purpose: To investigate the efficacy of photodynamic therapy with verteporfin for the treatment of patients with corneal neovascularization. Design: Prospective, non-comparative case series. Participants: Eighteen eyes of 18 patients with stable corneal neovascularization who were refractory to conventional treatment. Methods: The patients were treated with photodynamic therapy with verteporfin (6 mg/m2). Five patients were treated following penetrating keratoplasty, and 2 patients were treated before penetrating keratoplasty. Best corrected visual acuity and anterior segment photography were performed before and after treatment. The length of cumulative blood vessels and area of corneal neovascularization were measured. Main outcome measures: Vascular occlusion, best corrected visual acuity, cumulative blood vessel length, and corneal neovascularization area.

Conditions
-----------------
Corneal Neovascularization

Intervention / Treatment
-----------------
* Procedure: Photodynamic Therapy with Verteporfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically stable corneal neovascularization who were not improved after treatment with 1% prednisolone acetate eyedrops instilled 4 times a day for at least 1 month Exclusion Criteria: Individuals who had active keratitis with vessel proliferation, uncontrolled inflammation, active hepatitis or clinically significant liver disease, or porphyria or other porphyrin sensitivity

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Photodynamic Therapy with Verteporfin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases

Official Title
-----------------
Personalized Evidence-based Treatment Improves Survival in Patients With Invasive Breast Cancer

Conditions
-----------------
Breast Cancer-specific Survival

Intervention / Treatment
-----------------
* Drug: neoadjuvant/adjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women with stage I-III disease who survived at least 12 months post-diagnosis Exclusion Criteria: Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- |
| CDSS (MedicBK) Analysis<br> | Drug: neoadjuvant/adjuvant therapy<br>* chemotherapy/endocrine therapy/surgery/radiotherapy<br>|
| Core Laboratory Analysis<br> | Drug: neoadjuvant/adjuvant therapy<br>* chemotherapy/endocrine therapy/surgery/radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of guideline-consistent and personalized EBM recommendations | The percentage of guideline-consistent and personalized EBM recommendations acted on by clinicians in patients with first invasive breast cancer. All discrepancies between routine and CDSS-recommended treatment resulting in frame of guideline-consistent therapy and personalized EBM therapy will be adjudicated by core laboratory. | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer-specific survival | All deaths due to breast cancer-related causes | 3-year | 
| Quantify the performance of the CDSS (MedicBK) algorithm | Quantify the performance of the CDSS (MedicBK) algorithm for presents treatment suggestions in frame of guideline-based therapy and personalized EBM therapy: the sensitivity, specificity, NPV, and PPV | 3-year | 
| Predictors | Predictors of guideline-consistent and personalized EBM adherence | 3-year |
Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to establish patient preferences in regards to common complications of cervical cancer treatments, and to compare these preferences to those of medical providers who care for cervical cancer patients. These preferences will be determined via a interview using the Standard Gamble, which is a well-recognized method for establishing utilities.

Official Title
-----------------
Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subject has to have been diagnosed with early cervical cancer (Stage I or II) within the last 3 years and/or take care of patients with cervical cancer and identify her or himself as one of the following: gynecologic oncologist, radiation oncologist, physician's assistant or nurse. Subjects must be ≥18 and <61 years old. Exclusion Criteria: Subjects who are unable to read and speak English proficiently will be excluded. Proficiency will be assessed by the investigator enrolling patients. Subjects who do not have capacity to consent will not be included in this study. Subjects may not be investigators on this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 61 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 |
| --- | --- |
| Patients<br> | |
| Providers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilities of complications associated with cervical cancer treatment. |  | At time of interview |
Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma

Official Title
-----------------
Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Advanced Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: SOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older ECOG performance score of two or less Child Pugh class A• Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL presence of extrahepatic measurable lesion no prior systemic therapy (excluding sorafenib) adequate marrow, liver, kidney function written informed consent Exclusion Criteria: prior systemic therapy (excluding sorafenib) hypersensitivity to study drugs active gastrointestinal bleeding other malignancies within five years pregnant or breastfeeding female symptomatic brain or leptomeningeal metastasis clinically significant heart disease interstitial pneumonia peripheral neuropathy grade one or more uncontrolled infection renal impairment prior use of investigational drug or therapy within 4 weeks

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOX<br>TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14 | Drug: SOX<br>* TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1 14<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) | The time from study enrollment to tumor progression or death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival | 2 years | 
| response rate | response rate by RECIST 1.1 | 2 years | 
| toxicity | toxicity according to NCI-CTCAE v.3.0 | 2 years |