linjc16/ctgov huggingface dataset:
Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit

Study Overview
=================
Brief Summary
-----------------
The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm. After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)

Official Title
-----------------
Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit

Conditions
-----------------
Solid Tumor, Adult

Intervention / Treatment
-----------------
* Procedure: Chemotherapy prevalidation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age <80 (if age>70 years, a G8 score>14 is required) ECOG<3 Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting) Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15 Familiar with digital tools Exclusion Criteria: Emergency patient feeling unease with the use of a smartphone

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nurse then patient digital prevalidation of chemotherapy<br>Outpatient Chemotherapy prevalidation will done with the help of a nurse, using the digital application, for cycle 2 and 3. by the patient alone, using the digital application, for cycle 4 and 5. | Procedure: Chemotherapy prevalidation<br>* Outpatient Chemotherapy prevalidation will done with the help of a nurse, using the digital application, for cycle 2 and 3. by the patient alone, using the digital application, for cycle 4 and 5.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the digital application | Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
digital application, outpatients chemotherapy, chemotherapy validation
Understand the Association Between Peritoneal Dialysis Status and Gene Polymorphisms of VEGF and KDR

Study Overview
=================
Brief Summary
-----------------
Peritoneal dialysis (PD) is an effective and successful way of renal replacement therapy. The initial transport status is related to distribution of blood vessels and micro inflammation state in peritoneum before PD. Vascular endothelial growth factor(VEGF) and its receptor, kinase insert domain containing receptor(KDR) may play important roles on initial transport status. This study include 200 PD patients from Renji Hospital in Shanghai, China. According to the 4h D/P Cr within three months of starting PD therapy, we analyzed the association between the polymorphisms of VEGF and KDR and initial peritoneal transport property.

Official Title
-----------------
Gene Polymorphisms of VEGF and KDR Are Associated With Initial High Transport Status in Peritoneal Dialysis

Conditions
-----------------
Peritoneal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are Han Chinese; Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization; Patients successfully complete the first peritoneal equilibration test(PET); Follow up regularly in our PD center. Exclusion Criteria: Patients from hemodialysis to peritoneal dialysis; Patients who need peritoneal dialysis due to transplant-renal loss;
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 |
| --- | --- | --- |
| The relationship between VEGF and KDR Gene polymorphisms and initial transport status in peritoneal dialysis | According to the 4h dialysate over plasma ratio for creatinine （D/P Cr） within three months of starting PD therapy, patients were divided into high transport(H) or high average transport(HA) (H/HA) group and low transport(L) or low average transport(LA) (L/LA) group. Gene polymorphisms of selected VEGF and KDR SNPs were analyzed using extracted blood DNA from these patients. We aimed to investigate the relationship between VEGF and KDR gene polymorphisms and initial peritoneal transport property. | For each patient, the outcome would be cross sectional measured at the time the patient does first/initial Peritoneal Equilibration Test. The data collection time period of the study is within 3 months. |
Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization

Study Overview
=================
Brief Summary
-----------------
Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary endpoint of the study.

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus need for coronary revascularization age > 18 years Exclusion Criteria: clinical contraindications to prolonged double antiplatelet therapy life expectancy < 1 year lack of 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 |
| --- | --- |
| PCI<br>diabetic patients undergoing percutaneous coronary intervention | Procedure: PCI<br>* percutaneous coronary intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac mortality rate | incidence of cardiac death | 4-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac event rate | incidence of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization) | 4-year follow-up |
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

Detailed Description
-----------------
Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.

Official Title
-----------------
Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: PMI-150 (intranasal ketamine)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is scheduled for elective orthopedic surgery or procedure Exclusion Criteria: patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter. | Drug: PMI-150 (intranasal ketamine)<br>* PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.<br>|
| Placebo Comparator: 2<br>Placebo at time 0 and specified time points thereafter. | Drug: Placebo<br>* Placebo (intranasal) at time 0 and scheduled times thereafter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of pain intensity difference |  | 0-6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthopedic, ketamine, pain
Quality of Life Following Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn what impact the surgery has upon the participant's sense of health, sexual and urinary quality of life.

Detailed Description
-----------------
To define impact on quality of life issues for patients undergoing radical prostatectomy. This study will distribute a questionnaire to patients who are being scheduled for radical prostatectomy, both before and after surgery, to assess the impact on quality of life issues. This will provide important information regarding the temporal return of issues pertaining to quality of life.

Official Title
-----------------
Quality of Life Following Radical Prostatectomy

Conditions
-----------------
Prostatic Neoplasms, Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients scheduled to undergo radical prostatectomy at Stanford Exclusion Criteria: - Patients treated with neoadjuvant or adjuvant hormonal therapy or radiation therapy

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

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 |
| --- | --- | --- |
| urinary and bowel habits |  | before and after surgery | 
| sexual and hormonal index as self-reported in the questionnaires |  | before and after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life
Collaborative Wilms Tumour Africa Project

Study Overview
=================
Brief Summary
-----------------
Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment. A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year. The hypothesis is that 2 year event free survival will be 50%, with <10% failure to complete treatment and <10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.

Detailed Description
-----------------
Patients are treated according to standard care. Data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.

Official Title
-----------------
Collaborative Wilms Tumour Africa Project

Conditions
-----------------
Wilms Tumour

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 18 years Diagnosis Wilms tumour Exclusion Criteria: * None

Ages Eligible for Study
-----------------
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 |
| --- | --- |
| Wilms tumour<br>Children diagnosed with a Wilms tumour receive SIOP PODC Wilms tumour treatment; preoperative chemotherapy, surgery and postoperative chemotherapy (= standard care). One group of patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival | Percentage of patients with no event after two years of follow up. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wilms tumour, Childhood cancer, Africa
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair

Study Overview
=================
Brief Summary
-----------------
Blood supply to the sigmoid colon during open abdominal aortic aneurysm (AAA) repair is at risk. Ischemia of the sigmoid colon after AAA repair is potentially devastative. No reliable measures to prevent it are available and the underlying mechanisms are poorly understood. The aim of this study is to describe intraoperative perfusion patterns of the sigmoid colon during open AAA repair and their potential impact on postoperative outcome.

Official Title
-----------------
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Diagnostic Test: visible light spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing elective open AAA repair between 2013 and 2016 were eligible for this study Exclusion Criteria: No informed consent emergency cases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sigmoid perfusion<br>Measured by visible light spectroscopy | Diagnostic Test: visible light spectroscopy<br>* Sigmoid perfusion was assessed using visible light spectroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| saturation in the sigmoid colon | Perfusion rate | intraoperative day |
The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.

Detailed Description
-----------------
This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.

Official Title
-----------------
Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: drainage
* Procedure: non-drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ready to receive single-side TKA Be evaluated as ASA 1-2 degree before operation Exclusion Criteria: coagulation disorder peripheral vessel diseases contraindication of surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: drainage<br>A drainage will be applied in this group. | Procedure: drainage<br>* Applying a drain tube during TKA procedure<br>|
| Active Comparator: without drainage<br>Non-drainage will be applied in this group. | Procedure: non-drainage<br>* No drain tube will be applied during TKA procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of bleeding volume in perioperative period | The difference between baseline Hct collected before operation and Hct collected one week after operation | before operation and one week after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling of the lower extremities | perimeter of lower extremities before and after operation | one week after operation | 
| Range of motion | Range of motion of the knee received operation | one week after operation | 
| Pain | Use the Visual Analogue Scale to estimate the pain and its score ranges from 0 to 10. The higher the score is, the more severe pain the patient is feeling. | one week after operation |
Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Although the diagnosis and therapy of HCC have being improved, the poor prognosis still remains. To reduce the mortality and improve the effectiveness of diagnosis and therapy, it is important to detect the protein biomarkers which are associated with HCC tumor progression and may be useful as potential diagnosis or therapeutic targets. SMP30 (senescence marker protein 30)(serum regucalcin), which we have previously identiﬁed from Guangxi HCC cDNA expression library by the SEREX approach, is one of the hepatocellular carcinoma associated antigens [4] Serum antibody response to SMP30 in various patients using the methods of Western-blot and ELISA and showed that antibody to SMP30 existed mainly in HCC patients (39.8%), especially in the one with alpha-fetoprotein (AFP) negative

Official Title
-----------------
Role of Serum Regucalcin in Diagnosis of Hepatocellular Carcinoma

Conditions
-----------------
Role of Serum Regucalcin in Diagnosis of HCC

Intervention / Treatment
-----------------
* Diagnostic Test: serum regucalcin antibody


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed cases of HCC (be based on NCCN guidelines triphasic CT and AFP or liver biopsy) Adult patients Both genders are eligible. Informed consent obtained from subject or subject's legal representative Exclusion Criteria: Patient with other malignancies. Patients with advanced comorbidities except for renal failure. Prior chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| patients with HCC<br> | Diagnostic Test: serum regucalcin antibody<br>* serum regucalcin antibody<br>|
| patients with hepatitis C Ab positive<br> | Diagnostic Test: serum regucalcin antibody<br>* serum regucalcin antibody<br>|
| patients with hepatitis C Ab negative<br> | Diagnostic Test: serum regucalcin antibody<br>* serum regucalcin antibody<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum regucalcin in HCC patients | This work aims to assess serum regucalcin antibodies level using ELISA in HCC patients to: evaluate its potential role as biomarker in diagnosis. evaluate potential associations of the presence of serum regucalcin antibody with HCC patients' clinico-epidemiological parameters. | 1-12-2016 to 1-12-2017 |
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
The safety and efficacy of FTY720 is being evaluated in patients who receive a kidney transplant.

Official Title
-----------------
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing their first kidney transplant Male or female age 18 to 65 years Exclusion Criteria: Patients in need of second kidney transplant or multi-organ transplants.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FTY720|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
-----------------
Kidney, Transplantation, Rejection, Immunosuppression