linjc16/ctgov huggingface dataset:
Clinical Frailty Scale Validation in Patients Scheduled for Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
Major vascular operations put the body under stress. We are trying to find out if the general health of a patient and the stress resulting from surgery can lead to the development of complications after surgery as well as increase the length of time spent in hospital. There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty.

Official Title
-----------------
Clinical Frailty Scale Validation in Patients Scheduled for Vascular Surgery

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Other: Frailty assessment tools


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending vascular pre assessment clinic Age > 60 - Exclusion Criteria: Refusal or inability to provide informed consent. Patients under 60 years of age. Patients not undergoing a vascular procedure. -

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Frailty assessment tools|There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical frailty scale validation in preoperative assessment of patients scheduled for vascular surgery | Identify a tool that will assist us to identify patients who are at risk of frailty. | June 2018 |
Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

Detailed Description
-----------------
We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Official Title
-----------------
A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy
* Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 75 years with histologically proven adenocarcinoma of the colon or rectum no severe major organ dysfunction WHO performance status of 0 or 1 Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) Exclusion Criteria: age >= 75 severe major organ dysfunction WHO performance status of >1 Stage I or Stage IV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: 1<br>12 cycles of oxaliplatine based adjuvant chemotherapy | Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy<br>* oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles<br>|
| Active Comparator: 2<br>8 cycles of oxaliplatine based adjuvant chemotherapy | Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy<br>* oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 5 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival liver metastasis-free survival |  | 5 years after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxaliplatine, colorectal cancer, chemotherapy
Study on Nation-wide Health Care Quality Information Openness and Transparency Mechanism Establishment

Study Overview
=================
Brief Summary
-----------------
Research objectives To provide people with sufficient information regarding health care and to improve its quality, this research endeavors to discuss the establishment of a health care information openness and transparency mechanism within the framework of the National Health Insurance system. This research also evaluates whether the transparency of health care quality information makes care givers provide better quality. Meanwhile, when appropriate information and quality index are presented to patients, patients shall have more knowledge about what they are dealing with, hence less misunderstanding between hospitals and patients would occur. Research Methods To revise indicators based on international trends, related literature and the need of people. To present 50 sets of quality indicator statistically on the website, and provide updated information about the first 10 sets. To analyze and explain the outcome and purposes of the indicator to the public. To estimate the possible trend for the coming year, and provide adaptive strategy. To promote the website, and hold workshops in all six regions of Taiwan. To make the website linked to the top 5 most populated official and unofficial websites. To respond to questions on the forum of the website daily, and maintain the system, update the website regularly. To complete the acceptability survey on health care institutions and people.

Official Title
-----------------
Study on Nation-wide Health Care Quality Information Openness and Transparency Mechanism Establishment

Conditions
-----------------
Valuable Suggestions to Improve Health Care Quality Transparent and Accessible Medical Care

Intervention / Treatment
-----------------
* Behavioral: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient ; healthy subjects patients Exclusion Criteria: The plan excluded child / children and other minors who were the target respondents, mainly to investigate the medical information for public acceptance of the site, child / children is not suitable, so as to adults as the main investigation.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: questionnaire|This research tool was a written questionnaire, did not do invasive or the subjects are exposed to physical danger on the experiment, so now there is no harm in this research and test more than minimal risk.|

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
-----------------
Health care quality, information openness, health care information website
Impact of Covid-19 Pandemic on Management of Head and Neck Cancers

Study Overview
=================
Brief Summary
-----------------
Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths. Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.

Official Title
-----------------
Observational Study Evaluating the Impact of the Covid-19 Pandemic on the Management of Patients With Head and Neck Cancer in the Maxillofacial Surgery Department

Conditions
-----------------
Head and Neck Cancer, Covid19, Patient Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient diagnosed with cancer of the upper aero digestive tract patient benefiting from a medical consultation patient benefiting from a multidisciplinary consultation meeting for treatment decision between 01/03/2020 and 28/02/2021. Exclusion Criteria: patient diagnosed with cancer other than upper aero digestive tract cancer patient whose treatment decision was made before 01/03/2020 (date considered as the beginning of the epidemic at the CHU Amiens-Picardie).

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 |
| --- | --- | --- |
| Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment | Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment for patients with H&N cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and Neck Cancer, upper aero digestive tract cancer, Covid19, patient care
Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

Conditions
-----------------
Myopia, Progressive

Intervention / Treatment
-----------------
* Drug: low concentration atropine (0.01%)
* Drug: low concentration atropine (0.025%)
* Drug: low concentration atropine (0.05%)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age of the screening stage is 3-15 years, both sexes; One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8; Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required; Informed consent from the guardian and the child. Exclusion Criteria: strabismus, amblyopia or other ocular abnormalities; The presence of systemic disease abnormalities; have taken myopia control treatment in the past month; Allergic to low concentration atropine or sulfuric acid drugs.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 15 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: 0.01% atropine<br>0.01% atropine eye drop | Drug: low concentration atropine (0.01%)<br>* 0.01% atropine eye drop<br>|
| Experimental: 0.025% atropine<br>0.025% atropine eye drop | Drug: low concentration atropine (0.025%)<br>* 0.025% atropine eye drop<br>|
| Experimental: 0.05% atropine<br>0.05% atropine eye drop | Drug: low concentration atropine (0.05%)<br>* 0.05% atropine eye drop<br>|
| Other: cross-over<br>first year: placebo second year: 0.05% atropine eye drop | Drug: low concentration atropine (0.05%)<br>* 0.05% atropine eye drop<br>Drug: Placebo<br>* Placebo eye drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of SE changes over -0.75D |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AL change |  | 2 years |
Microvascular and Cardiac Dysfunction in Paroxysmal Nocturnal Hemoglobinuria and Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how abnormal blood flow in the small vessels (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH) or sickle cell disease leads to poor functioning of the heart and kidney. To test this question, the investigators will perform imaging tests (contrast ultrasound perfusion imaging) to look at the flow and function of these microvessels and compare this information to heart and kidney function. To further look at this question, patients who have PNH will be studied before and after starting a new drug (Soliris) that decreases damage to blood cells. In patients with sickle cell disease, patients will be studied at baseline (not during a pain crisis) and also during a pain crisis if one develops.

Official Title
-----------------
Microvascular and Cardiac Dysfunction in Paroxysmal Nocturnal Hemoglobinuria and Sickle Cell Disease

Conditions
-----------------
Rheologic Disease, Sickle Cell Disease, Paroxysmal Nocturnal Hemoglobinuria

Intervention / Treatment
-----------------
* Other: Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of PNH or SCD Age > 18 years old Exclusion Criteria: Pregnant or lactating women Presence of significant right to left shunting Allergy to ultrasound contrast agent Reactive airways disease Significant peripheral or coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Control<br>Age matched healthy subjects | Other: Imaging<br>* Contrast ultrasound perfusion imaging and complete echocardiography<br>|
| Sickle Cell Patients<br>Patients with established SCD | Other: Imaging<br>* Contrast ultrasound perfusion imaging and complete echocardiography<br>|
| Paroxysmal Nocturnal Hemoglobinuria patients<br>Patients with PNH | Other: Imaging<br>* Contrast ultrasound perfusion imaging and complete echocardiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular perfusion | Myocardial microvascular blood flow (MBF) and capillary blood velocity (CBV) on study day. Renal MBF on study day Skeletal muscle MBF and CBV on study day Myocardial MBF and CBV during hyperemia Skeletal muscle CBV during hyperemia | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheology, Sickle cell, Paroxysmal nocturnal hemoglobinuria, contrast ultrasound
A Phase 3 Clinical Study of KW-3357 in Patients With DIC

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC criteria.

Official Title
-----------------
A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria

Conditions
-----------------
Disseminated Intravascular Coagulation (DIC)

Intervention / Treatment
-----------------
* Drug: KW-3357


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese Association for Acute Medicine-defined DIC criteria score >= 4 Antithrombin activity <= 70% Written informed consent from patient or guardian Exclusion Criteria: Anamnesis or complication of serious drug allergy Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis Pregnant, nursing, or possibly pregnant woman Possibility for the promotion of bleeding by concomitant use of heparin

Ages Eligible for Study
-----------------
Minimum Age: 20 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: KW-3357<br> | Drug: KW-3357<br>* Intravenous infusion once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of patients with adverse events | up to 6 days (or discontinuation) | 
| DIC resolution | Japanese Association for Acute Medicine-defined DIC criteria score < 4 | 6 days (or discontinuation) | 
| DIC score | Based on the Japanese Association for Acute Medicine-defined DIC criteria | Screening, 2, 3, 4, 5, 6 days (or discontinuation) | 
| Mortality |  | 28 days | 
| Organ symptoms | Sepsis related organ failure assessment score | Screening, 4, 6 days (or discontinuation) | 
| Severity | The Acute Physiology and Chronic Health Evaluation II score | Screening, 4, 6 days (or discontinuation) | 
| Plasma antithrombin activity |  | Screening, 2, 3, 4, 5, 6 days (or discontinuation) |
Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

Study Overview
=================
Brief Summary
-----------------
Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.

Official Title
-----------------
Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.

Conditions
-----------------
Left Bundle Branch Area Pacing

Intervention / Treatment
-----------------
* Device: Left bundle branch area pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic or non-ischemic cardiomyopathy Left ventricular ejection fraction ≤35% despite optimal medical therapy Left bundle branch block with QRS ≥130 milliseconds Exclusion Criteria: Previously implanted intra-cardiac material

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 |
| --- | --- |
| LBBAP<br>Patients implanted with a dual-chamber DF-1 cardioverter-defibrillator. Ventricular tachy sensing is performed via an IS-1 pacing lead placed in the interventricular septum. | Device: Left bundle branch area pacing<br>* A dual-chamber DF-1 defibrillator is implanted. Left bundle branch area pacing is performed for cardiac resynchronization therapy.<br>* Other names: Cardioverter-defibrillator implantation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful defibrillation at 35 Joules. | After manual induction of ventricular fibrillation, a 35 Joules will be delivered with the implanted defibrillator. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from ventricular fibrillation induction to defibrillation shock. | After manual induction of ventricular fibrillation, the duration of appropriate ventricular sensing will be measured until the 35 Joules shock is delivered. | 24 hours | 
| Number of appropriate and inappropriate arrhythmic episodes. | The occurrence of appropriately or inappropriately detected episodes with a high ventricular rate ≥170 beats-per-minute will be recorded. | 6 months |