linjc16/ctgov huggingface dataset:
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether supplemental perioperative oxygen significantly decreases the incidence of post-Cesarean endometritis and wound infection among women who undergo Cesarean section after the onset of labor.

Detailed Description
-----------------
Women undergoing cesarean section after rupture of membranes or onset of labor are randomized in a one to one ratio to either normal or supplemental perioperative oxygen during cesarean section and for two hours afterwards.

Official Title
-----------------
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-Cesarean Endometritis and Wound Infection

Conditions
-----------------
Wound Infection or Endometritis Post Cesarean Section

Intervention / Treatment
-----------------
* Procedure: supplemental perioperative oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent a clinically indicated cesarean delivery after the onset of labor or rupture of membranes Exclusion Criteria: Cesarean delivery prior to the onset of labor or rupture of membranes emergent cesarean delivery general endotracheal anesthesia clinical chorioamnionitis HIV infection less than 16 years of age

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>supplemental perioperative oxygen | Procedure: supplemental perioperative oxygen<br>* increased perioperative oxygen verses non-interventional oxygen<br>|
| No Intervention: 2<br>Normal | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection |  | within two weeks of cesarean section | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women undergoing Cesarean section after the onset of labor
A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty

Official Title
-----------------
Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added

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

Intervention / Treatment
-----------------
* Drug: Ketorolac
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total knee arthroplasty Age > 18 Tolerance for study drugs Written informed consent 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br> | Drug: Saline<br>* 1 ml infiltration 4 ml intraarticular bolus injection of placebo<br>|
| Active Comparator: Ketorolac<br> | Drug: Ketorolac<br>* 30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac<br>* Other names: Toradol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Consumption | Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request |  | within 48 hours after surgery | 
| Pain Intensity Scores During Walking | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) | 6-24 hours postoperatively | 
| Home Readiness | Ability to meet discharge criteria (home readiness) | time to fulfilment of discharge criteria | 
| Length of Hospital Stay |  | From the day of surgery until discharge | 
| Pain Intensity During Daily Activity | Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible) | 16 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Arthroplasty
Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack

Study Overview
=================
Brief Summary
-----------------
Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.

Official Title
-----------------
Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack

Conditions
-----------------
MRI, Diagnosis of TIA

Intervention / Treatment
-----------------
* Other: microangiopathic burden


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with probable TIA with Regression of symptoms within 24 hours (unilateral motor or sensory disorders affecting the face and / or limbs , language disorder, blindness of an eye or amputation of a visual field) Patients with possible AIT with 2 of these symptoms associated: fear of heights, diplopia, dysarthria, disorders of swallowing, loss of balance, isolated sensory symptoms affecting only part of a limb or hemiface. Patient who have had a brain MRI. Patient over 18 year-old. Patient who give their non opposition to participate at the study. 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnosis of AIT<br>Patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of AIT and having an MRI within 7 days of TIA. | Other: microangiopathic burden<br>* to determine the value of the global microangiopathic burden on the prediction of early stroke risk in a homogeneous cohort of TIA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke recurrence within 90 days, | The stroke recurrence within 90 days is determined via a clinical consultation or telephone call to the patient with a structured questionnaire. | 90 days |
Venous Thrombo-embolic Complication prévention in Pelvic Surgery

Study Overview
=================
Brief Summary
-----------------
Pelvic fracture surgery are very high thrombotic risk surgery with about 10% to 50% venous thrombo embolic complications and 0.5% to 10% of pulmonary embolism. The ST JOSEPH's Hospital have almost 60 cases per year . Following a fatal pulmonary embolism per operatory the team has set up a venous exploratory protocol before surgery. This protocol includes a venous doppler ultrasound of lower limbs associated to a abdo pelvic scanner in the 48hours before surgery. The aim is to evaluate this new protocol efficacy on prevention of thrombo embolic complications in pelvic fracture surgery.

Official Title
-----------------
Venous Thrombo-embolic Complication prévention in Pelvic Surgery

Conditions
-----------------
Venous Thromboembolism, Pelvic Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: VENOUS exploration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pelvic fracture with surgery indication age above 18 years Exclusion Criteria: pelvic fracture without surgery indication

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 |
| --- | --- |
| VENOUS exploration<br> | Diagnostic Test: VENOUS exploration<br>* venous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major thrombo-embolic events |  | Day 10 after surgery |
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Official Title
-----------------
A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: TD-4208
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or female subject 40 years of age or older Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential Subject is capable of performing reproducible spirometry maneuvers Subject has post-bronchodilator FEV1/FVC ratio <0.7 Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines) Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal Subject has a current or past smoking history of at least 10 pack-years. Exclusion Criteria: Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents Subject has been hospitalized for COPD or pneumonia within 12 weeks Subject requires long-term oxygen therapy (>15 hours a day)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: 44 mcg<br>TD-4208 | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Experimental: 88 mcg<br>TD-4208 | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Experimental: 175 mcg<br>TD-4208 | Drug: TD-4208<br> <br> * Other names: revefenacin;|
| Experimental: 350 mcg<br>TD-4208 | Drug: TD-4208<br> <br> * Other names: revefenacin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) |  | Baseline to 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Chronic Obstructive Pulmonary Disease
Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.

Official Title
-----------------
Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.

Conditions
-----------------
Anorectal Fistula

Intervention / Treatment
-----------------
* Procedure: LIFT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 65 years Complex anal fistula defined as anterior fistulas in women branched fistulas fistulas in patients with anal incontinence fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division. Exclusion Criteria: Crohn's disease in the rectum Previous LIFT surgery on same side Patient already treated with seton > 3 weeks Not able or willing to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Seton through fistula 6 months prior to LIFT | Procedure: LIFT<br>* Ligation of intersphincteric fistula tract<br>|
| Active Comparator: Control<br>Seton through fistula 3 weeks prior to LIFT surgery | Procedure: LIFT<br>* Ligation of intersphincteric fistula tract<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence or non-healing of anal fistula one year after LIFT surgery | 1 year | 
| Complication | Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorectal fistula, LIFT, Seton
Role of Hypofractionated Radiotherapy With Concurrent Gemcitabine in Treatment of Urinary Bladder Carcinoma

Study Overview
=================
Brief Summary
-----------------
Estimate the response to modified hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer patients . Estimate local control, relapse free survival, overall survival and bladder preservation rate. Evaluate the toxicity of a modified hypofractionated chemoradiotherapy protocol for patients with invasive bladder cancer.

Official Title
-----------------
Role of Hypofractionated Radiotherapy With Concurrent Gemcitabine in Treatment of Urinary Bladder Carcinoma

Conditions
-----------------
Urinary Bladder Cancer

Intervention / Treatment
-----------------
* Radiation: Chemoradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pathologically confirmation of transitional cell carcinoma . Non metastatic invasive bladder cancer (TNM0) Any age group ≥ 18 years. Non pregnant female patients. Exclusion Criteria: - Other pathology than Transitional cell carcinoma Metastatic Patient Age less than 18 years

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

| Intervention/Treatment |
| --- |
|Radiation: Chemoradiation|Hypofractionated radiotherapy with concurrent Gemcitabine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer | Estimate Disease free survival . | baseline |
A Compassionate Use (CU) Program of Odronextamab

Study Overview
=================
Brief Summary
-----------------
Provide compassionate use of odronextamab

Conditions
-----------------
Relapsed or Refractory (R/R) Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL), B-Cell Non-Hodgkin Lymphoma (NHL), High-Grade B-Cell Lymphoma (HGBCL)

Intervention / Treatment
-----------------
* Drug: Odronextamab


Participation Criteria
=================
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Odronextamab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Study Overview
=================
Brief Summary
-----------------
keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases. Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.

Official Title
-----------------
Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: corneal tomography scans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification. Contact lens intolerance. Thinnest location is more than 400 um. Maximum keratometry (Kmax) between 48 and 64 D. Clear cornea with no Vogt's striae. Exclusion Criteria: Previous corneal surgery. Grade IV with corneal scarring. Concurrent corneal disease in addition to KC. Autoimmune or systemic connective tissue diseases.

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 |
| --- | --- |
| keratoconus group<br>patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included | Device: corneal tomography scans<br>* corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly | The changes of anterior corneal surface including ﬂat (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly | 1 month |