linjc16/ctgov huggingface dataset:
Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

Study Overview
=================
Brief Summary
-----------------
This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

Detailed Description
-----------------
The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop system group to do similar or better.

Official Title
-----------------
Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index: Comparison Between Manual Perfusion and Automated Perfusion

Conditions
-----------------
Postoperative Sedation

Intervention / Treatment
-----------------
* Device: Closed-loop anesthesia system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status 1-3 Abdominal aorta surgery Exclusion Criteria: Pregnant women Neurological or muscular disorder

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

| Intervention/Treatment |
| --- |
|Device: Closed-loop anesthesia system|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global score (calculated parameter which depicts the performance of the system) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, Sedation
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection.

Official Title
-----------------
Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Ivermectin + colchicine
* Drug: Colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written informed consent prior to performing study procedures. Currently hospitalized and requiring medical care for non-sever COVID-19. One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection). Exclusion Criteria: Tocilizumab use. Mechanical ventilation Requirement of oxygen supplementation >8L/min on admission

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivermectin + colchicine + standard care<br>In addition to the local standard of care for COVID 19 patients, the patient will receive: Ivermectin + Colchicine | Drug: Ivermectin + colchicine<br>* In addition to the local standard of care for COVID 19 patients, the patient will receive Ivermectin + colchicine<br>|
| Active Comparator: Colchicine + standard care<br>In addition to the local standard of care for COVID 19 patients, the patient will receive: Colchicine | Drug: Colchicine<br>* In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine<br>|
| No Intervention: standard care<br>Patients will receive Standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of oxygen requirement |  | 3 months |
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models. Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.

Official Title
-----------------
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Conditions
-----------------
Non Muscle Invasive Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven urothelial bladder cancer Intermediate risk NMIBC ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60% Imaging study excluding upper urinary tract TCC Exclusion Criteria: Pregnant and lactating women; Advanced co-existing medical or psychiatric disorders; Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding; History of allergy to sulfonamide drugs; Concomitant investigational medications.

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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A<br>Patients undergoing treatment with oral celecoxib | Drug: Celecoxib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first recurrence |  | 5 years | 
| Safety assessed by description of grade 1-4 adverse events |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermediate risk, Cox-2 inhibitors
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer

Official Title
-----------------
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Conditions
-----------------
THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy. 3 8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes Normal laboratory values: leucocyte ≥ 4×109/L neutrophil ≥ 1.5×109/L platelet ≥ 100×109/L Hemoglobin ≥ 10g/L ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent Exclusion Criteria: Patients have used drugs according to protocol Uncontrolled infection of Bacterial or virus or fungal Patients with other malignant tumor Uncontrolled brain metastases Female patients during their pregnant and lactation period, or patients without contracep

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemcitabine<br> | Drug: gemcitabine<br>* gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | from the first cycle of treatment (day one) to two month after the last cycle |
Telemedicine and Nursing Home

Study Overview
=================
Brief Summary
-----------------
Telemedicine-based care provides remote health and social care to maintain people's autonomy and increase their quality of life. The rapidly aging population has come with a significant increase in the prevalence of chronic diseases and their effects, and thus the need for increased care and welfare. This solutions give a new opportunity for diagnosis, treatment, education, and rehabilitation, and make it possible to monitor patients with a number of chronic diseases. It also reduces socioeconomic disparity with regard to access to care and gives equal chances to patients from urban and rural areas. This a randomized trial of telemedicine versus usual care alone to reduce hospitalization and emergency hospital admissions for Nursing Home Residents . After an initial assessment , each participant is monitored by teleconsultation on six occasions over 12 months. Patients with usual care have an initial and a 12 months assessments.

Official Title
-----------------
Impact of Telemedicine on Avoiding Emergency Hospital Admissions and Hospitalization for Nursing Home Residents

Conditions
-----------------
Elderly, Multimorbidity

Intervention / Treatment
-----------------
* Other: Telemedicine
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly over 60 years Resident in nursing homes Resident with multiples chronic diseases with at least two comorbidities Having given free and informed consent in writing and signed by himself and / or his legal representative Exclusion Criteria: Resident unaffiliated or not beneficiary of Social Security Resident with a life-threatening disease

Ages Eligible for Study
-----------------
Minimum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Usual care and telemedicine consultations during12 months. | Other: Telemedicine<br> <br> Other: Usual Care<br> <br> |
| Active Comparator: Usual care alone<br>Usual care during12 months. | Other: Usual Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Proportion of patients who had an admission to the emergency or unscheduled hospitalization in health service or surgery | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAST | Cost / effectiveness of telemedicine based on the MAST model (Model of Assessment of Telemedicine ). | 12 months |
Cleavage Pattern of Embryos and Oxidative Parameters

Study Overview
=================
Brief Summary
-----------------
To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

Detailed Description
-----------------
To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

Official Title
-----------------
Is Abnormal Cleavage Pattern of Embryos Associated With Different Oxidative Parameters Compared With That of Normally Cleaving Embryos? A Prospective Cohort Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: oxidative stress measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing IVF for the treatment of infertility Exclusion Criteria: Age <18 or >45 years old Patients with no embryos with direct cleavage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Patients<br>Oxidative stress measurement in cleavage state embryos | Diagnostic Test: oxidative stress measurement<br>* oxidative stress measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | Implantation rate (positive BHCG) | 1 year | 
| clinical pregnancy rate | Clinical pregnancy as defined by appearance of gestational sac on ultrasound | 1 year |
Determining Chewing Performance Level in Children

Study Overview
=================
Brief Summary
-----------------
The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.

Detailed Description
-----------------
The KCPS was developed by physical therapists who had expertise in pediatric swallowing disorders. This scale could be used as a practical tool to define chewing disorders as a common language for professionals due to its quick and easy to use features. However, its reliability in other professions has not been verified. The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.

Official Title
-----------------
Inter-rater Reliability in Determining Chewing Performance Level in Children

Conditions
-----------------
Chewing Problem

Intervention / Treatment
-----------------
* Diagnostic Test: Karaduman Chewing Performance Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Typical developing children Children with cerebral palsy (CP) Above the age of 2 years Exclusion Criteria: Children who were under the age of 2 years Who used any medicine and/or oral appliances that may affect chewing performance Who had a previous evaluation of chewing function and received any chewing training

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with cerebral palsy<br>Children who will be referred to pediatric dentistry above the age of 2 years. | Diagnostic Test: Karaduman Chewing Performance Scale<br>* For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.<br>|
| Children with typical development<br>Children who will be referred to pediatric dentistry above the age of 2 years. | Diagnostic Test: Karaduman Chewing Performance Scale<br>* For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karaduman Chewing Performance Scale | The Karaduman Chewing Performance Scale is a 5 level ordinal scale between 0 to 4. Level 0 indicates Normal chewing, level 4 means No biting and chewing. Higher levels mean worse chewing performance level. | 2 months |
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis. The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter. As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)

Official Title
-----------------
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients

Conditions
-----------------
End Stage Renal Failure, Hemodialysis

Intervention / Treatment
-----------------
* Drug: Ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders, over 18 years, Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days, Written informed consent Social security Exclusion Criteria: Antibiotic therapy during selection phase, Partial or complete catheter occlusion during selection phase, Venous pressure at dialysis connection > 300 mmHg, Known allergy to ethanol, Patient involved in any other clinical trial or in the exclusion period Severe co-morbidity Acute or chronic infectious disease Evolutive neoplasia, HIV, HCV positive serology at inclusion, Scheduled surgery

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
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethanol|Examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The catheters dysfunction rate |  | as partial or complete occlusion or infection associated with dialysis catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dialysis quality is also examined (urea reduction rate, total ultrafiltration) |  | as partial or complete occlusion or infection associated with dialysis catheter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ethanol, lock solution, infection
A Long-Term Safety Study of OZURDEX® in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

Conditions
-----------------
Retinal Vein Occlusion, Macular Edema, Uveitis, Posterior

Intervention / Treatment
-----------------
* Drug: dexamethasone 700 μg intravitreal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular oedema following either BRVO or CRVO or non-infectious uveitis Requires treatment with OZURDEX® Exclusion Criteria: Current participation in any clinical 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OZURDEX®<br>OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice. | Drug: dexamethasone 700 μg intravitreal implant<br>* dexamethasone 700 μg intravitreal implant administered according to general clinical practice.<br>* Other names: OZURDEX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Patients Reporting Serious Adverse Events |  | 2 years | 
| Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest | The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement. | 2 years |