linjc16/ctgov huggingface dataset:
A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.

Detailed Description
-----------------
In this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. The investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. The investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.

Official Title
-----------------
A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer

Conditions
-----------------
Surgery, Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: colorectal cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically diagnosed as colorectal cancer Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery Exclusion Criteria: The patient refused to join the study The patient refused to collect the biological sample The patient refused to follow up
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: colorectal cancer surgery|Any surgery for primary tumor of colorectal cancer, including palliative resection, simple bowel stoma and exploratory surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival time | For patients received radical resection of colorectal cancer, disease-free survival time is defined as time from the surgery to any recurrence of disease or death, recorded in months. | 2 yeas after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time | Overall survival time is defined as time from the surgery to death, recorded in months. | 2 yeas after surgery | 
| Pathological TNM stage | The pathological TNM stage included the pathological T stage, pathological N stage and M stage. The pathological T and N stage is decided according to the removed specimen of the primary tumor by the pathologist after surgery. The M stage is decided according to the imaging tests as CT, MRI and PET-CT. | 1 month after surgery |
Maintenance of Vitamin D Level by UVB Radiation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.

Detailed Description
-----------------
The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.

Official Title
-----------------
How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?

Conditions
-----------------
Vitamin D Status

Intervention / Treatment
-----------------
* Radiation: Broadband UVB
* Radiation: Broadband UVB
* Radiation: Broadband UVB
* Radiation: Broadband UVB
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years Healthy Exclusion Criteria: Sun bed use Holiday or business travel south of 45 degrees latitude during trial Illness Drug addiction Pregnancy Lactating

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Body surface area: 88 % | Radiation: Broadband UVB<br>* UVB dose: 1 SED every week<br>|
| Active Comparator: Group 2<br>Body surface area: 22 % | Radiation: Broadband UVB<br>* UVB dose: 4 SED every second week<br>|
| Active Comparator: Group 3<br>Body surface area: 88 % | Radiation: Broadband UVB<br>* UVB dose: 1 SED every second week<br>|
| Active Comparator: Group 4<br>Body surface area: 88 % | Radiation: Broadband UVB<br>* UVB dose: 1 SED every month<br>|
| No Intervention: Group 5<br>Body surface area: 0 % | Other: Control group<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D (nmol/l) | Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level. | Monthly during 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathyroideahormone (pmol/l) | To investigate whether parathyroideahormone is influenced by the UVB radiations. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, UVB, Frequency, Body surface area, Dose-Response
Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Study Overview
=================
Brief Summary
-----------------
This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.

Official Title
-----------------
Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Conditions
-----------------
Hepatitis C

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period. Exclusion Criteria: Subjects who received daclatasvir as part of a clinical trial. Subjects who received daclatasvir for any indication other than local approved. Contraindications included in the approved Mexican prescribing information.

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 |
| --- | --- |
| CHC patients in Mexico<br>patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | adverse events (AEs) on treatment with DCV in patients with chronic hepatitis C treated by doctors at participating sentinel sites for the CNFV in Mexico | Approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Adverse Events by Age |  | Approximately 24 months | 
| Distribution of Adverse Events by Gender |  | Approximately 24 months | 
| Distribution of Adverse Events by Interruption or Switch of Medication |  | Approximately 24 months | 
| Distribution of Adverse Events by Concomitant Medication |  | Approximately 24 months | 
| Distribution of Adverse Events by Race |  | Approximately 24 months |
TARC After alloSCT in Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
Relapsed and refractory Hodgkin's lymphoma (HL) patients may experience long-term survival after allogeneic transplant (alloSCT), but disease recurrence represents the main cause of treatment failure. PET (positron-emission tomography) -positive patients after alloSCT have a dismal outcome. Serum TARC (thymus and activation-regulated chemokine) is produced by Reed-Sternberg cells and may be a marker of disease. Our study was aimed at assessing whether TARC levels after alloSCT were correlated to disease status and whether TARC monitoring could increase the ability to predict relapse.

Official Title
-----------------
Serum Thymus and Activation-regulated Chemokine (TARC) Level Monitoring May Predict Disease Relapse Detected by PET Scan After Reduced Intensity Allogeneic Stem Cell Transplantation in Hodgkin's Lymphoma Patients

Conditions
-----------------
Hodgkin's Lymphoma Patients Who Underwent an Allogeneic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: no treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin's lymphoma patients who underwent an alloSCT at Fondazione IRCCS Istituto Nazionale dei Tumori and who were monitored by PET and TARC before and after alloSCT from 2009 Exclusion Criteria: Hodgkin's lymphoma patients who underwent an alloSCT who were not monitored by PET or/and TARC

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 |
| --- | --- |
| no treatment<br> | Other: no treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between disease status and serum TARC level | Serum TARC level was measured before alloSCT in Hodgkin's lymphoma patients and after alloSCT. The median time interval after alloSCT was 47 days. PFS was estimated at one year based on TARC value. | One year after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between TARC levels and PET results after alloSCT | We selected TARC values done on the days of PET to assess a cut-off value of TARC that was correlated to a positive or negative PET | Before alloSCT, monthly during the first 6 months after alloSCT and every 2 months until 2 years of follow-up, then at the time of clinical check-up (usually every 6 months) |
Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR

Detailed Description
-----------------
Total Knee Arthroplasty (TKA) remains the surgical gold standard treatment for patients suffering from end stage osteoarthritis (OA) of the knee. However, due to the high demand and scarce medical resources, the waiting time for surgery is astoundingly lengthy. Controversies are shown on numerous studies on whether physical functionality and mental status decline or remain stable over the waiting period. This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR.

Official Title
-----------------
Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty

Conditions
-----------------
Knee Arthroplasty, Knee Arthroplasty, Total, Knee Replacement, Total, Replacement, Total Knee, Total Knee Replacement, Life Quality, Health-Related Quality Of Life, Osteoarthritis Of Knee

Intervention / Treatment
-----------------
* Other: Health Quality of Life Questionnaire Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with symptomatic osteoarthritis Enlisted on the TKA surgical waiting list Ethnic Chinese Fluent in Cantonese Exclusion Criteria: Evidence of cognitive dysfunction like dementia Surgery scheduled within 30 days Severe co-morbidity preluding participation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Health Quality of Life Questionnaire Assessment|Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Self-Rated Questionnaire SF36 and Health Related Quality of Life (HRQoL) 15D questionnaire were used as outcome measurement for functionality and disability assessment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) | Questionnaire | From March 2013 to December 2016 | 
| Self-Rated Questionnaire SF36 | Questionnaire | From March 2013 to December 2016 | 
| Health Related Quality of Life (HRQoL) 15D | Questionnaire | From March 2013 to December 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRQoL, Quality of Life, End Stage Osteoarthritis, Total Knee Arthroplasty, WOMAC, SF 36, Total Knee Replacement
Extended High-frequency Hearing and Speech Perception

Study Overview
=================
Brief Summary
-----------------
This study examines the effects of low-pass filtering speech on speech perception.

Official Title
-----------------
Extended High-frequency Hearing and Speech Perception

Conditions
-----------------
Low-pass Filtering Speech

Intervention / Treatment
-----------------
* Diagnostic Test: Reduced extended high-frequency audibility


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: native speakers of American English normal hearing 250-8000 Hz Exclusion Criteria: non-native speakers of American English hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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: Normal-hearing listeners<br> | Diagnostic Test: Reduced extended high-frequency audibility<br>* This study examines the effects of low-pass filtering speech on speech perception.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech recognition or localization score | Speech recognition or localization scores are assessed using alternative forced choice procedures implemented with custom software scripts (e.g. in Matlab) | Day 1 |
Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

Study Overview
=================
Brief Summary
-----------------
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.

Detailed Description
-----------------
The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Official Title
-----------------
A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.

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

Intervention / Treatment
-----------------
* Drug: cabergoline
* Drug: controlled-release levodopa / carbidopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson Disease Must be experiencing sleep akinesia Exclusion Criteria: Current treatment with other dopamine agonists Nocturnal hallucinations Dementia

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cabergoline|nan|
|Drug: controlled-release levodopa / carbidopa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDSS, UPDRS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI, PGI, Epworth Sleepiness Scale, PDQ-39 |  |  |
Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
In children undergoing pulmonary resection, the diaphragm function is evaluated using ultrasound before and after surgery to evaluate the incidence of diaphragm dysfunction after pulmonary resection. In addition, we examine if there is a relationship between diaphragmatic dysfunction and pulmonary complications, including postoperative lung atelectasis.

Official Title
-----------------
Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery: Prospective Observational Study

Conditions
-----------------
Diaphragm Dysfunction

Intervention / Treatment
-----------------
* Device: Diaphragm ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients under 7 years undergoing lung resection Exclusion Criteria: Asthma Myopathy or neuropathy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients undergoing lung resection<br> | Device: Diaphragm ultrasound<br>* Diaphragm ultrasound is performed at the following three time points. At the entrance of the operating room before induction of anesthesia 1 hour after surgery 24 hours after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in diaphragmatic thickness | Changes in diaphragmatic thickness, from time frame 1 to 3 | 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery | 
| Changes in diaphragm thickening fraction | Changes in diaphragm thickening fraction, from time frame 1 to 3 | 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery | 
| Changes in the length of diaphragmatic tidal excursion | Changes in the length of diaphragmatic tidal excursion, from time frame 1 to 3 | 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery |
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer

Official Title
-----------------
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer

Conditions
-----------------
Advanced Gastric Cancer

Intervention / Treatment
-----------------
* Drug: FLOT Regimen
* Drug: FLO Regimen or FLOT Regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Female or male aged 18 years and over Histologic or cytologic confirmation of advanced gastric cancer Stage III-IV (AJCC 7th) ECOG: 0-2 Have tumor sample that can be tested for BRCA1 mRNA expression Negative pregnancy test for women of childbearing potential Neutrophile granulocyte greater than 1.5×10^9/L Hemoglobin greater than 10g/dL Platelet greater than 100×10^9/L Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR) ALT or AST not greater than 1.5x ULRR Creatinine clearance no less than 60ml/min Exclusion Criteria: Have at least another primary malignant tumor Active infection Chemotherapy with experimental drug within 3 weeks before the start of study therapy Women who are pregnant or breast feeding Weight loss greater 10% within 6 weeks before the start of study 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?
-----------------

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: Group A<br>FLOT Regimen | Drug: FLOT Regimen<br>* FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel<br>|
| Experimental: Group B<br>FLO Regimen or FLOT Regimen | Drug: FLO Regimen or FLOT Regimen<br>* FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 12 months | 
| Response Rate |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, BRCA1