linjc16/ctgov huggingface dataset:
Cytomegalovirus (CMV) Perilymphatic Fluid

Study Overview
=================
Brief Summary
-----------------
In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

Detailed Description
-----------------
Data on etiology of hearing loss and CMV status are collected. Perilymphatic liquid is collected after cochleostomy using a 1ml seringue. The drop of liquid is deposited on a Guthrie card; on another card, a drop of blood is deposited on another card. CMV PCR (polymerised chain reaction) is then performed in order to assess for the presence of CMV. The sensibility, specificity, positive and negative positive values are then calculated.

Official Title
-----------------
Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss

Conditions
-----------------
Hearing Loss, Cochlear, Cytomegalovirus Congenital

Intervention / Treatment
-----------------
* Biological: collection of sample of perilymphatic fluid during cochlear implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- |
| Experimental: collection of sample of perilymphatic fluid during cochlear implantation<br>collection of sample of perilymphatic fluid during cochlear implantation | Biological: collection of sample of perilymphatic fluid during cochlear implantation<br>* collection of sample of perilymphatic fluid during cochlear implantation and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in hearing loss.<br>* Other names: collection of perilymphatic fluid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of CMV PCR in perilymphatic fluid | CMV PCR in perilymphatic fluid | 7 days after the collection of the sample (biological collection) |
Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

Study Overview
=================
Brief Summary
-----------------
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

Detailed Description
-----------------
Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension

Official Title
-----------------
A Randomized Active-controlled Multi-site Double-masked Study to Evaluate the Safety and Tolerability of 3 Concentrations of QLS-101 Versus Timolol Maleate Preservative Free (PF) 0.5% Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: QLS-101
* Drug: Timolol Maleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual acuity +1.0 logMAR or better Willing to give informed consent Ability to washout from current intraocular pressure lowering medications - Exclusion Criteria: Severe glaucomatous damage Previous glaucoma intraocular or laser surgery Refractive surgery Ocular infection or inflammation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS-101 0.5%<br> | Drug: QLS-101<br>* Ophthalmic solution 1x daily<br>|
| Experimental: QLS-101 1%<br> | Drug: QLS-101<br>* Ophthalmic solution 1x daily<br>|
| Experimental: QLS-101 2%<br> | Drug: QLS-101<br>* Ophthalmic solution 1x daily<br>|
| Active Comparator: Timolol Maleate 0.5% preservative free ophthalmic solution<br> | Drug: Timolol Maleate<br>* Ophthalmic solution 1x daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety | Number of participants with treatment-related adverse events will be monitored | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular hypotensive efficacy | Number of participants with intraocular pressure reduction from baseline will be calculated. | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elevated intraocular pressure
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.

Official Title
-----------------
A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: OSI-211 (Liposomal Lurtotecan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed relapsed ovarian cancer. Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan). One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin. At least three weeks since prior chemotherapy and recovery from any related toxicities. At least four weeks since prior radiotherapy and recovery from any related toxicities.

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

Sexes Eligible for Study
-----------------
Female

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: OSI-211 (Liposomal Lurtotecan)|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
-----------------
Ovarian Cancer
Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that in critically ill patients there is significant differences between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.

Detailed Description
-----------------
The sudy hypothesis is that in critically ill patients there is a significant difference between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples. The study aim is determine the agreement between electrolyte levels measure by formal laboratory serum analysis and point-of-care blood gas analysis. Also, to determine the agreement between electrolyte levels measured on simultaneous arterial and venous blood samples, using both serum and whole blood samples.

Official Title
-----------------
Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing

Conditions
-----------------
Electrolyte Values

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18 years or older admitted to the intensive care unit Patients who have arterial and central venous access insitu for clinical management purposes. Patients who consent to inclusion in the study, or if the patient is not competent, the next of kins' consent. Exclusion Criteria: Nil-

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 |
| --- | --- | --- |
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair

Study Overview
=================
Brief Summary
-----------------
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.

Official Title
-----------------
A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair

Conditions
-----------------
Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
-----------------
* Device: SeriACL Device ACL Reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: Complete rupture of the ACL Passive flexion >= 120° and passive extension = contralateral knee MCL grade 2 or less Pre-injury Tegner score >= 4 Informed Consent Major Exclusion Criteria: Prior ACL reconstruction. Severe pain, swelling, or redness Complete PCL tear Complex menisci tears Contralateral knee ligament injury OA > Grade II

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Intervention/Treatment |
| --- |
|Device: SeriACL Device ACL Reconstruction|Long-term Bioresorbable ACL Scaffold|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Adverse Events |  | 12 months | 
| KT-1000 Arthrometer Knee Laxity |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Surveys |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACL, Ligament
Fenoldopam in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.

Official Title
-----------------
Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery

Conditions
-----------------
Kidney Failure, Acute

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Fenoldopam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass Exclusion Criteria: Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 365 Days

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline blinded infusion | Drug: Placebo<br>* Saline continuous infusion during cardiopulmonary by pass at 1 ml/h<br>* Other names: saline;Drug: Fenoldopam<br>* Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.<br>* Other names: corlopam;|
| Active Comparator: Fenoldopam<br>Drug infusion | Drug: Placebo<br>* Saline continuous infusion during cardiopulmonary by pass at 1 ml/h<br>* Other names: saline;Drug: Fenoldopam<br>* Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.<br>* Other names: corlopam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls |  | End of surgery and 12 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls |  | End of surgery and 12 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary bypass, pediatric cardiac surgery, acute renal failure, renal biomarkers, fenoldopam, Focus on optimization of perfusion during pediatric CPB
Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.

Official Title
-----------------
Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury: a Retrospective Cohort Analysis

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult non-cardiac, non-obsteric, non- kidney elective surgery patients Exclusion Criteria: patients aged <18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP <100 mmHg

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 |
| --- | --- | --- |
| incidence and odds ratio of postoperative acute kidney injury | incidence and odds ratio of postoperative acute kidney injury | 30 days postoperatively in hospital |
Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.

Detailed Description
-----------------
Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.

Official Title
-----------------
Official Title is Required by the WHO and ICMJE

Conditions
-----------------
Injury of Other and Multiple Parts of Small Intestine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing heart valve replacements under cardiopulmonary bypass Exclusion Criteria: Patients who die during or after operation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- |
| patients with cardiac surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of gut dysfunction | At different time points, gut dysfunction is graded according to previous criterion. | eight months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of cardiopulmonary bypass | Record the duration of cardiopulmonary bypass | Eight months | 
| The duration for aortic artery clamping |  | eight months |
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

Conditions
-----------------
Acquired Bleeding Disorder, Bleeding During/Following Surgery

Intervention / Treatment
-----------------
* Procedure: standard therapy
* Drug: activated recombinant human factor VII
* Drug: activated recombinant human factor VII
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone allogeneic or autologous stem cell transplantation Exclusion Criteria: Known or suspected allergy to trial product Participation in other trials with unapproved drugs or trials with equal or similar objective

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Procedure: standard therapy<br>* Standard treatment of bleeding<br>Drug: placebo<br>* Placebo<br>|
| Experimental: Low dose<br> | Procedure: standard therapy<br>* Standard treatment of bleeding<br>Drug: activated recombinant human factor VII<br>* Two days repeated treatment regimen - low dose administered i.v. (into the vein)<br>|
| Experimental: Medium dose<br> | Procedure: standard therapy<br>* Standard treatment of bleeding<br>Drug: activated recombinant human factor VII<br>* Two days repeated treatment regimen - medium dose administered i.v. (into the vein)<br>|
| Experimental: High dose<br> | Procedure: standard therapy<br>* Standard treatment of bleeding<br>Drug: activated recombinant human factor VII<br>* Two days repeated treatment regimen - high dose administered i.v. (into the vein)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on bleeding, defined as change in bleeding score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion requirements |  |  | 
| Bleeding evaluation |  |  | 
| Adverse events |  |  |