linjc16/ctgov huggingface dataset:
Mammographic Density and the Risk of Tumor Recurrence in Asian Women: a Case-control Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcome in patients with invasive breast cancer after surgery

Official Title
-----------------
Mammographic Density and the Risk of Tumor Recurrence in Asian Women: a Case-control Study

Conditions
-----------------
Case Control Study

Intervention / Treatment
-----------------
* Other: Mammographic breast density at diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with invasive breast cancer between 2004 and 2009 who had undergone surgery and had the mammographic breast density ascertained before, or at, diagnosis. Exclusion Criteria: Women diagnosed with invasive breast cancer between 2004 and 2009 who had not undergone surgery or who had no mammographic breast density ascertained before, or at, diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Breast cancer women with known recurrences<br>Breast cancer women with known recurrences (locoregional recurrence and distant metastasis) | Other: Mammographic breast density at diagnosis<br>* Mammographic breast density at diagnosis<br>|
| Breast cancer women without recurrences<br>Breast cancer women without recurrences | Other: Mammographic breast density at diagnosis<br>* Mammographic breast density at diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard ratios for recurrence |  | 2004 to 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard ratios for death |  | 2004 to 2009 |
Study Evaluating MAC-321 in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Assess the clinical activity of MAC-321 administered IV as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). Tumor response will be assessed following modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

Official Title
-----------------
A Phase 2, Open-Label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Advanced Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Intervention / Treatment
-----------------
* Drug: MAC-321


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection. Prior treatment with at least 1 conventional approved therapeutic regimen. Subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (CPT-11), 5 fluorouracil (5-FU), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible Exclusion Criteria: Other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the ICF (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin) Prior radiotherapy to >25% of bone marrow Prior exposure to MAC-321

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MAC-321|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
-----------------
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal, Colorectal Neoplasms
Supermicrosurgical LVA for Lymphedema Treatment

Study Overview
=================
Brief Summary
-----------------
LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of the LVs and the RVs, and the relative distance between them. Most published literatures have focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow. Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this study, we aimed to establish the basis of selecting the proper anastomotic orientation, based on the size and comparative size discrepancy between LV and RV. To the best of our knowledge, this is the first report to focus on this subject.

Official Title
-----------------
Supermicrosurgical Lymphatic Venous Anastomosis for Lymphedema Treatment

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Other: LVEEA
* Other: LVESA
* Other: LVSEA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lymphedematous lower limbs (International Society of Lymphology stage I-III) between March 2016 to October 2018 were included Exclusion Criteria: Patients whose data were missing will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 underwent supermicrosurgical LVA<br>Patients underwent supermicrosurgical LVA by a single surgeon from March 2016 to October 2018. | Other: LVEEA<br>* lymphaticovenous end-to-end<br>Other: LVESA<br>* lymphaticovenous end-to-side<br>Other: LVSEA<br>* lymphaticovenous side-to-end<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival or failure | The primary free flap outcome was determined as its survival or failure. | up to 3 months |
Hospital for Special Surgery Hip Arthroplasty Cohort

Study Overview
=================
Brief Summary
-----------------
Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes. Most health related quality of life studies in THA and TKA only report data up to twelve months post-operatively. In addition, most large studies of TKA and THA have been performed in Medicare patients. While these databases are important in providing population based data, Medicare studies do not permit any direct patient contact, and provide no information on patients under 65. Existing studies have also investigated predictors of patient outcome at one and two years after joint arthroplasty. However, very little is known about predictors of prosthesis failure, and there are no validated clinical indicators for choosing one prosthesis model over another. Once a device is FDA approved, there is very little motivation on the part of the developer to perform complete post-marketing research, despite the importance of these data to the public health. Most existent studies are not powered to compare differences between models. The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.

Official Title
-----------------
Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Hip Arthroplasty Cohort

Conditions
-----------------
Hip Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Undergoing total knee arthroplasty at HSS Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires. Exclusion Criteria: No other exclusion criteria;this is a non-interventional study which only involves filling out questionnaires.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Study Overview
=================
Brief Summary
-----------------
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).

Detailed Description
-----------------
The CARE-TCM is a prospective, multi-center, patient registry study. Eligible ALS patients with TCM treatments will be enrolled in the registry. After enrollment, this research collects the individual characteristics of patients' status. Longitudinal follow-up data are collected from both patients (primary caregivers) and their treating neurologists every 3 months for 5 years. The aims of the CARE-TCM are to: 1) explore the general characteristics of ALS patients with TCM and; 2) assess the effectiveness and safety of various TCMs on ALS based on nationwide registry outcome collecting process.

Official Title
-----------------
China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years and older. Patients with possible, laboratory supported probable, probable, or definite ALS according to the revised El Escorial criteria. ALS patients treated with traditional Chinese medicine. Exclusion Criteria: Patients who refuse informed consent.

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 |
| --- | --- |
| Amyotrophic lateral sclerosis patients<br>Amyotrophic lateral sclerosis patients with traditional Chinese medicine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Survival | The time from disease onset to death, tracheostomy, or permanent assisted ventilation | Through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Death owing to any causes | Through study completion, an average of 3 months | 
| Rate of Disease Progression | (48-total ALSFRS-R)/symptom duration (months) | Through study completion, an average of 3 months | 
| Rate of Forced Vital Capacity (FVC) Decline | The slope of decline of forced vital capacity (FVC) to assess the respiratory function. | through study completion, an average of 3 months | 
| Rate of Body Mass Index (BMI) Decline | The slope of decline of body mass index (BMI) to assess the disease progression. | Through study completion, an average of 3 months |
Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
To investigate natural killer (NK) cell activities, circulating cytokine levels and peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill patients.

Detailed Description
-----------------
Blood samples were collected < 24 hours after admission from 24 intensive care unit (ICU) patients and 24 age-, sex-, and body mass index (BMI)-matched healthy controls. NK cell activities, cytokine concentrations and cytokine production by PBMCs and lipopolysaccharide (LPS)-stimulated PBMCs were measured.

Official Title
-----------------
Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients For healthy controls: nondiabetic and nonobese subjects Exclusion Criteria: For healthy controls: diabetes; history/presence of significant metabolic disease; pregnancy or breast-feeding; acute or chronic infection; liver disease; kidney disease; gastrointestinal disease; subjects taking any drugs or supplements
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 |
| --- | --- |
| ICU patient<br>Critically ill patients who were enrolled less than 24 hours after ICU admission. | |
| Control<br>Age-, sex-, and BMI-matched healthy subjects. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK cell activity | NK cell activity (%) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL (Interleukin)-12 | IL-12 (pg/mL) | Baseline | 
| hs-CRP (high-sensitivity C-reactive protein) | hs-CRP (mg/dL) | Baseline |
Closing the Gap in Care in Seronegative Inflammatory Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. Six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.

Official Title
-----------------
Closing the Gap in Care in Seronegative Inflammatory Arthritis: From Identification to Implementation of Treating to Target: A Randomized Trial of Feedback, Education, and Behavioural Change

Conditions
-----------------
SpA, PsA

Intervention / Treatment
-----------------
* Behavioral: Education and Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Canadian Rheumatologist Exclusion Criteria:

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No education or feedback<br>Rheumatologists randomized to this treatment arm receive no additional education or feedback about their systematic assessments of patients | |
| Experimental: Education and Feedback<br>Rheumatologists randomized to receive education and feedback participate in six web conferences designed to improve their systematic assessments of their patients, and are given feedback about their performances | Behavioral: Education and Feedback<br>* Rheumatologists are rated on how systematically they assess their patients, and receive six sessions of university accredited education about systematic assessments of patients with seronegative arthritis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Systematic Assessments | Physicians in the Education and Feedback arm are assessed via a needs assessment to identify the care gaps for their patients with inflammatory arthritis. After the education and feedback, they complete a second chart audit and their improvements in assessments is recorded. | November 2012 - November 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seronegative Inflammatory Arthritis, SpA, PsA, Randomized, Behavioural Change
Schizophrenia Study In Adults

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study For Patients With Schizophrenia

Official Title
-----------------
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: talnetant
* Drug: risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must meet diagnostic criteria for schizophrenia. Exclusion Criteria: Patients with other psychotic disorders. Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition. Patients with a history of autistic disorder or another pervasive developmental disorder. Patients with epilepsy or a history of seizures requiring treatment. Patients who are excluded from taking the drug risperidone. Patients who pose a current serious suicidal or homicidal risk. Patients who are adequately stabilized on their treatment.

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: talnetant|nan|
|Drug: risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the PANSS total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Talnetant, schizophrenia, NK3 receptor antagonist, psychosis
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. The investigators hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure.

Detailed Description
-----------------
Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education of Integrated Traditional and Western Medicine is not known. The investigators hypothesized that a patient discharge education of Integrated Traditional and Western Medicine program would improve clinical outcomes in patients with chronic heart failure.

Official Title
-----------------
Discharge Education of Integrated Traditional and Western Medicine Reduces Re-hospitalization in Patients With Chronic Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Discharge Education of Chinese Medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for this study were admitted to the hospital with a diagnosis of heart failure and documented left ventricular systolic dysfunction (ejection fraction<0.40). Exclusion Criteria: CKD4 and CKD5

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient education and Chinese medicine<br>1-hour, one-on-one teaching session with a educator to the standard discharge education of Integrated Traditional and Western Medicine | Behavioral: Discharge Education of Chinese Medicine<br>* Discharge Education of Integrated Traditional and Western Medicine<br>|
| No Intervention: patient education<br>no discharge education | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of days hospitalized | total number of days hospitalized in the 84-day follow-up period. | 84 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Education, Chinese Medicine