linjc16/ctgov huggingface dataset:
Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

Study Overview
=================
Brief Summary
-----------------
The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for combination of pooling, nitrazine and ferning) for the detection of Preterm Prelabour Rupture of Membranes (PROM).

Detailed Description
-----------------
Prior studies of AmniSure have included a heterogeneous population of women with preterm and term pregnancies.10-12 No study to date has specifically addressed and been powered to detect the efficacy of AmniSure in pregnancies between 16+0 and 36+6 weeks. The objective of the proposed research is to evaluate the usefulness of AmniSure PAMG-1 rapid immunoassay in the evaluation of preterm prelabour rupture of membranes (PPROM) compared to standard detection of PPROM with a speculum examination for combination of pooling, nitrazine and ferning.

Official Title
-----------------
Detection of Preterm Prelabour Rupture of Membranes With AmniSure Placental Alpha Macroglobulin-1 Rapid Immunoassay

Conditions
-----------------
Preterm Premature Rupture of Fetal Membranes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation consent to enrollment Exclusion Criteria: vaginal bleeding active labor (cervical dilation > 2 cm or effacement > 80%) multiple pregnancy fetal anomalies placenta previa fluid loss per vagina > 7 days prior inclusion in the study
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPROM<br>All women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of Amnisure vs conventional testing for PPROM | After delivery, the charts will be reviewed and information will be used to determine the final diagnosis of membrane status as ruptured or intact on initial presentation and will be used to evaluate the accuracy of the AmniSure test results. | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm, placental alpha microglobulin-1, AmniSure, rupture of fetal membranes
Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery.

Detailed Description
-----------------
Laser in situ keratomileusis (LASIK) is the most commonly performed refractive surgical procedure for the correction of ametropia worldwide. Infectious keratitis, although rare, is a potentially devastating complication of LASIK, and it can lead to horrifying outcomes. Previous studies on antibiotic susceptibility of preoperative ocular bacterial flora focused primarily on intraocular surgeries with particular interests in endophthalmitis. This study was aimed at refractive surgeries with special interest in infectious keratitis after LASIK. Intraocular surgeries for cataract, glaucoma or retinal disease are performed mostly on aged patients at a large hospital on an inpatient or outpatient basis; however, most refractive surgeries are performed on young, healthy people in private clinics on an outpatient basis. The patient populations are therefore quite different between these two types of surgery. The aim of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery at an outpatient laser surgery clinic. Preoperative conjunctival swab samples are directly inoculated in culture media at the bedside before topical anesthetic or antibiotic application. Blood agar, chocolate agar, thioglycolate broth, Sabouraud dextrose agar, and Ogawa media are used for bacterial, fungal and mycobacterial cultures. Minimum inhibitory concentrations (MICs) of ofloxacin (OFX), levofloxacin (LEV), gatifloxacin (GAT), moxifloxacin (MOX), gemifloxacin (GEM) and other commonly used antibiotics are determined using an E-test.

Official Title
-----------------
Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

Conditions
-----------------
Bacterial Keratitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia patients scheduled for refractive surgery Exclusion Criteria: Active keratitis Current treatment of antibiotics (systemic or topical)
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 |
| --- | --- | --- |
| Minimum inhibitory concentrations of commonly used antibiotics are determined using an E-test. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotic susceptibility, bacterial flora, fluoroquinolone, LASIK, refractive surgery
Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer. The data from this retrospective study will be analyzed by the study Sponsor to aid in designing a prospective clinical trial for a new technology that offers a treatment alternative to standard of care defunctioning stoma in patients undergoing LAR for rectal cancer.

Official Title
-----------------
Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection for Rectal Cancer

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 18 years of age or older at the time the LAR surgery was performed. Having an open or minimally invasive colorectal resection with diverting loop ileostomy surgical procedure performed between January 15, 2015 and January 15, 2019 for treatment of a known or suspected malignant condition. Availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the LAR surgery. Exclusion Criteria: Planned surgical procedure is a Hartmann's procedure (surgical resection of the rectosigmoid colon with closure of the anorectal stump and formation of an end colostomy). Having a documented medical history of inflammatory bowel disease prior to the LAR surgery. Having a concomitant major surgical procedure performed in combination with the LAR surgery (e.g., colorectal resection with hepatectomy).

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 |
| --- | --- |
| LAR for rectal cancer<br>Retrospective chart review for surgical complications related to the LAR surgery, the stoma (diverting loop ileostomy) creation and the stoma reversal procedure after LAR for rectal cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Characterize the type and incidence of surgical complications related to the LAR, the stoma creation and the stoma reversal after LAR for rectal cancer. | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Anterior Resection
Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair

Study Overview
=================
Brief Summary
-----------------
Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone

Official Title
-----------------
Emergence Delirium and Recovery Profile in Patients Undergoing Cleft Lip and Palate Repair: Comparison of Combination of Morphine and Fentanyl With Fentanyl Alone

Conditions
-----------------
Anesthesia Emergence Delirium

Intervention / Treatment
-----------------
* Drug: MORPHINE PLUS FENTANYL
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 Patients Undergoing Cleft Lip And Palate Repair Exclusion Criteria: CNS Disorders Respiratory Infection GERD

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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 |
| --- | --- |
| Experimental: Morphine Plus Fentanyl<br> | Drug: MORPHINE PLUS FENTANYL<br>* Effect Of Morphine Plus Fentanyl On Emergence Delirium<br>|
| Active Comparator: Fentanyl only<br> | Drug: Fentanyl<br>* Effect Of Fentanyl Only On Emergence Delirium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Delirium ( PAED Scale) |  | 30 Minutes Postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain (FLACC Scale ) |  | 30 Minutes Postoperatively | 
| Saturation Of Oxygen (SpO2 in %) |  | 30 Minutes Postoperatively | 
| Temperature (degree Celsius) |  | 30 Minutes Postoperatively | 
| Heart Rate (Beats Per Minute) |  | 30 Minutes Postoperatively | 
| Respiratory Rate (Per Minute) |  | 30 Minutes Postoperatively |
iTotal Pilot Study of ConforMIS Custom Total Knee Implant

Study Overview
=================
Brief Summary
-----------------
To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant. Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).

Detailed Description
-----------------
The experimental design was changed based on enrollment hurdles to be a single cohort observational study where ConforMIS patients were enrolled and followed for 6 months with 6 minute walk used as the primary outcome measure.

Official Title
-----------------
CT-navigated, Patient-specific Custom Total Knee Replacement Versus Standard Total Knee Replacement: Comparison With a Marker-less Gait Analysis System and Validated Outcome Scores

Conditions
-----------------
Knee Arthroplasty, Total

Intervention / Treatment
-----------------
* Device: ConforMIS custom total knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - undergoing total knee arthroplasty Exclusion Criteria: - BMI >40

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ConforMIS<br>Subjects who receive a ConforMIS custom total knee implant. | Device: ConforMIS custom total knee<br>* Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Measured During 6-minute Walk Test | Subjects will walk for 6 minutes and the distance covered will be measured in feet. | 6 months |
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

Detailed Description
-----------------
Hip fractures are a serious public health problem. The current incidence is projected to increase fourfold worldwide by the year 2050. This affliction is obviously linked to the aging of the population and the absence of a systematic prevention of osteoporosis. This leads to the creation of a minimally invasive, or ever percutaneous, implantable osteosynthesis material which associates : the well-known reliability of osteosynthesis using screw-plate with barrel, the safety of the fixation with Surfix concept, locking the screws to the plate using lock-screws, a modularity thanks to the choice between 3 sizes of barrel, the creation of a simple material, easing the operative surgery by minimally invasive approach. The TRAUMAX answers to all those characteristics.

Official Title
-----------------
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Conditions
-----------------
Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman Age > 18 with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX Exclusion Criteria: Patient with an acute infection Patient with a major osseous deterioration which not allows a correct support of the screws in the bone Patient with an ASA score of 4 or 5 Patient whom the time between the fracture and the surgery could be higher than 8 days

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 |
| --- | --- | --- |
| The consolidation rate |  | 6 months after surgery | 
| The rate of complication due to the device |  | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention. |  | 3 and 6 months after surgery | 
| PMA score |  | 3 and 6 months after surgery | 
| operating time |  | during the surgery | 
| The duration of the use of the amplifier of brilliancy during the intervention |  | during the surgery | 
| The radiological position of the device |  | 5 days, 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mini-invasive, dynamic screw-plate, Surfix, Lock-screw
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects will be treated in repeating 4 week cycles.

Official Title
-----------------
Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2 or IFN Based Therapy

Conditions
-----------------
Melanoma, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: CC 5013


Participation Criteria
=================
Eligibility Criteria
-----------------
Understand and voluntarily sign an informed consent form. Able to adhere to the study visit schedule and other protocol requirements. Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug. Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC 5013|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
-----------------
Metastatic Melanoma, Metastatic Malignant Melanoma, Revimid, CC5013
Joint Stiffness Following Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
Our primary research question is to find out whether there is a genetic component to the development of joint contractures following knee surgery, through the application of lab techniques.

Detailed Description
-----------------
After total knee replacement surgery, some people develop joint stiffness, which is also called a joint contracture. Contractures cause the envelope of the knee (called the capsule) to stiffen and become rigid so the patient can no longer move their knee the way they used to. After stretching and other exercises, only a surgery can try and divide or remove the contracture. The main purpose of this research is to study the cause of the contracture and specifically if certain people are predisposed to contractures.

Official Title
-----------------
Capsular Changes in Joint Contractures Post-Knee Arthroplasty:A Case-Control Study

Conditions
-----------------
Joint Contracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -knee contractures post arthroplasty scheduled for arthrotomy with debridement of capsular tissue Controls will be patients scheduled for arthrotomy with debridement of capsular tissue for the other reasons(primary knee arthroplasty, ORIF of the knee secondary to trauma, ACL repair, amputation, elective joint arthroplasty with capsuloplasty etc.) Exclusion: transmissible disease (HIV, Hep B,C) confirmed or suspected neoplasia suspected infection

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 |
| --- | --- | --- |
| Gene expression |  | Dec 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
joint contracture, total knee arthroplasty
Prenatal Examination of Deletion 22q11 Syndrome : Thymic Dysgenesis THYMI Study

Study Overview
=================
Brief Summary
-----------------
22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult series despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease

Official Title
-----------------
Research of Thymix Dysgenesis in Prenatal Examination of Deletion 22q11 Syndrome

Conditions
-----------------
22q11 Deletion Syndrome Di George Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all prenatal diagnosis with FISH or CGH array of a fetal 22q11 deletion syndrome during the inclusion period. The pregnancy follow-up should be done one of the 44 french fetal medicine unit. Sonographic picture of 3 vessels slides should be communicated for independent review. Exclusion Criteria: no sonographic picture available

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prenatal diagnosis of a fetal 22q11 deletion syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thymic thoracic ratio  measurement on sonographic picture of the fetal 3 vessels slides will be done by independent investigator. |  | day 0 |