linjc16/ctgov huggingface dataset:
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track)

Study Overview
=================
Brief Summary
-----------------
Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP, procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and on the length of stay.

Official Title
-----------------
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection

Conditions
-----------------
Colorectal Postoperative Complication

Intervention / Treatment
-----------------
* Other: C-reactive protein dosage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper age to 18 years Planned hospital stay for a colonic resection with anastomosis without permanent or temporary digestive bypass Patient with pre-operative CRP lower or egal to 172 mg/L No opposition at the participation of the study Expected patient return home after surgery (or convalescent home or not medicalized institution) Exclusion Criteria: Patient under guardianship Protected or private patient freedom Minor patient Colectomy surgery with digestive bypass or digestive anastomosis Complex combined surgery (significantly intestinal resection associated, another surgical procedure that can interfere with postoperative CRP) General inflammatory disease susceptive to modify dosage values Anti-inflammatory therapy (AINS/ corticosteroids/ immunosuppressive) Patient unable to understand the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-reactive protein dosage<br> | Other: C-reactive protein dosage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein rate | The time of postoperative recovery will be compared to the CRP values at 3 postoperative days. The postoperative recovery is a composite endpoint defined by : no pain > 2 on the VAS scale presence of a gaseous bowel patient autonomy in terms of ambulation and body care (IRM 5-6) no fever | 3 postoperative days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRP, Postoperative complication, Length of stay
Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia

Study Overview
=================
Brief Summary
-----------------
Carotid endarterectomy (CEA) is a high risk surgical and anesthesiological procedure. It is an essential part of stroke-prevention strategies, however the incidence of CEA related peri-operative stroke is between 5% and 10%. These procedures can be performed either in general or regional anaesthesia. We hypothesized that an appropriate awake sedation is able to decrease patient's distress and an improved satisfaction can be reached.

Detailed Description
-----------------
We aim to explore the stress response of patients randomized according to different sedation protocols: (i) per os premedication only with alprazolam (BDZ group) or (ii) premedication with alprazolam combined with target control infusion (TCI) of propofol (BDZ+TCI) for awake carotid endarterectomy. A total of 50 consecutive patients with significant carotid artery stenosis will be enrolled into this prospective randomised study. All surgeries will be performed in regional anaesthesia. As premedication, all patients took 0.25 mg alprazolam 30 minutes before the procedure. After randomization 25 patients will be grouped to both arms of the study: either to sedation with target controlled propofol infusion, or to only premedication. Stress markers, such as cortisol plasma levels will be serially analysed: prior to surgery (T1), before (T2) and after release of carotid clamp (T3), at 2 (T4) and 24 post-operative hours (T5). Alprazolam levels were also measured before and after the surgery.

Official Title
-----------------
Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia

Conditions
-----------------
Perioperative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy, written informed consent - Exclusion Criteria: patient declines to participate in the study -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| major vascular events | acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack | at 30th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality and vascular events | death, acute coronary syndrome, myocardial infarction, stroke, transient ischemic attack | 5-year follow-up |
IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Official Title
-----------------
An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN)

Conditions
-----------------
Persistent Pulmonary Hypertension of the Newborn

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies < 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia Oxygenation index >15 and < 60 Exclusion Criteria: Congenital anomaly Large left to right intracardiac or ductal shunt Already on inhaled nitric oxide

Ages Eligible for Study
-----------------
Maximum Age: 72 Hours

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil<br>iv sildenafil | Drug: Sildenafil<br>* Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - incidence of treatment failure |  | Day 1-14 | 
| Need for inhaled nitric oxide or Extracorporeal membrane oxygenation |  | Day 1-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in oxygenation index |  | 6 & 12 hours | 
| Changes in differential saturation |  | 6 & 12 hours | 
| Duration of mechanical ventilation |  | Days 1-14 | 
| Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation |  | Days 1-14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPHN, persistent pulmonary hypertension of the newborn, sildenafil, iv
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.

Detailed Description
-----------------
Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles. Endpoint is response rate, secondary endpoints survival and toxicity.

Official Title
-----------------
Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma

Conditions
-----------------
Malignant Pleural Mesothelioma

Intervention / Treatment
-----------------
* Drug: Carboplatin and Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified malignant pleural Mesothelioma Age above 18 years Performance status 0-2 Exclusion Criteria: No previous chemotherapy Normal renal, liver and bone marrow function

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carboplatin and Vinorelbine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Feasibility |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Pleural Mesothelioma, Chemotherapy
Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References

Study Overview
=================
Brief Summary
-----------------
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Detailed Description
-----------------
Comparison study comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references. Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements

Official Title
-----------------
Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

Conditions
-----------------
Cardiac Output, Low

Intervention / Treatment
-----------------
* Device: non-invasive cardiac output monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age able and willing to participate provide written consent Exclusion Criteria: Unable to give written consent <18 years of age No or poor finger pulse, as determined through visual inspection for ischemic hands

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 |
| --- | --- |
| Group 1<br>Cardiac patients | Device: non-invasive cardiac output monitor<br>* Equivalence of Caretaker cardiac output reading to reference standard<br>* Other names: Equivalence of Caretaker cardiac output reading to reference standard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output performance comparison | Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min. | Change between several paired readings over the course of cardiac surgery (typically 2-4 hours) |
The Effect of Jinchuang Ointment (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the effect of a Chinese herb complex Jinchuang ointment (JCO) on the treatment of chronic nonhealing wounds in patients with Hansen's disease and its mechanism.

Detailed Description
-----------------
20 patients who were hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare, were recruited. Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds. Basic data of each case were collected, and a monthly wound record was used to follow the condition of the wound healing of these patients.

Official Title
-----------------
The Evaluation of Treatment of Leprosy Wounds With Traditional Chinese Herbal Medicine Complex Jingchuang Ointment

Conditions
-----------------
Leprosy, Hansen's Disease, Wounds

Intervention / Treatment
-----------------
* Other: Jingchuang Ointment(JCO)
* Other: Regular Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hanson's patients Meet the definition of chronic wound Exclusion Criteria: Kidney disease Parathyroid disease Malignant tumors.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jingchuang Ointment(JCO) group<br>Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds, last 3 months. Jingchuang Ointment (JCO) is made by Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan) | Other: Jingchuang Ointment(JCO)<br>* Applied once a day on the wounds<br>* Other names: Chuang Song Zong Pharmaceutical Co., Ltd. (Taiwan);|
| Other: Regular treatment group<br>Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. | Other: Regular Treatment<br>* Do not use the Jingchuang Ointment(JCO), as the regular treatment as usual.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The size of wound area | Length times width | Changes in wound size in 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Jinchuang Ointment (JCO), anti-inflammation, Leprosy, Hansen's disease (HD), wounds
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Study Overview
=================
Brief Summary
-----------------
Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Detailed Description
-----------------
Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

Official Title
-----------------
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial

Conditions
-----------------
Psychomotor Agitation

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (<2hr) Exclusion Criteria: children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room. | Drug: Midazolam<br>* preoperatively injected intravenous 0.1 mg/kg midazolam<br>|
| Experimental: Ketamine<br>Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room. | Drug: Ketamine<br>* Preoperatively injected intravenous 1mg/kg ketamine<br>* Other names: Ketamine HCl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Agitation | The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher. | During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child, ketamine, midazolam
After Induction Chemotherapy of DP Plus DDP Concurrent Radiotherapy With and Without Bevacizumab Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open controlled multicenter phase II clinical study. The SPSS statistical software estimation of sample size, selection of the initial treatment of locally advanced head and neck squamous cell carcinoma in 120 patients, such as to achieve the desired results, considering expanding the clinical, according to the proportion of 1:1 were randomly divided into two groups, all patients were taken, docetaxel + cisplatin 2 cycles of induction chemotherapy 、Concurrent chemoradiotherapy（tomotherapy+cisplatin）, The experimental group was added with AVASTIN.

Official Title
-----------------
Docetaxel (T), Cisplatin (P) After Induction Chemotherapy With and Without Cisplatin (P) Concurrent Radiotherapy (X) Plus Bevacizumab (B) Phase II Clinical Study

Conditions
-----------------
Head and Neck Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women are not limited, requirements of ECOG0-2, age 18-70 years old, pathological stage III (NCCN2012), had not received radiotherapy and chemotherapy, expected to survive more than 3 months, the routine testing, were in the normal range, signed the informed consent Exclusion Criteria: Do not meet the above criteria; allergic to docetaxel and AVASTIN, or metabolic disorders; associated with gastrointestinal bleeding, perforation and other serious diseases; severe liver disease, kidney disease, respiratory disease or unable to control diabetes, hypertension and other chronic disease; heart disease clinical symptoms; there is peripheral nervous system disorders or have obvious mental disorder and disorders of the central nervous system; active phase >CTCAE2 clinical severe infection; a history of organ transplantation (including bone marrow transplantation of autologous peripheral stem cell transplantation); pregnant, lactating women, women of childbearing age and spouse refused to take effective means of contraception contraception; no legal capacity, continue to influence medical or ethical reasons for who

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR |  | three month after ratiotherapy |
Care Pathways of Acute Heart Failure Patients: Impact on In-hospital Mortality.

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a prospective observational study to describe the different pre-hospital and in-hospital pathways of patients with acute heart failure (AHF) and their association with in-hospital mortality.

Detailed Description
-----------------
Prospective observational national multicentric study in 26 centres. Between june 2014 and october 2018 The investigators collected data about baseline characteristics, first recourse, in-hospital places of care and places of hospitalizations. Lengths of care and lengths of hospitalization. Collected data of each patient were reported on a specific assessment tool. The investigators ran a univariate analysis and logistic regression between steps of the care pathway and in-hospital mortality. The main result was validated by an analysis with a propensity score: association between a hospitalization in cardiology and in-hospital mortality.

Official Title
-----------------
Care Pathways of Acute Heart Failure Patients: Impact on In-hospital Mortality. A French National Prospective Survey

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting to hospital with Acute Heart Failure according to the physician in care 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Death of the patient during hospital stay reported by the physician in charge | Between patient's inclusion in the study and it's hospital discharge, up to one year |