linjc16/ctgov huggingface dataset:
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.

Official Title
-----------------
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial

Conditions
-----------------
Premature Rupture of Membranes at Term

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: PGE2 gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature rupture of membranes at 37 or more weeks Single live fetus in cephalic presentation Exclusion Criteria: Women in labour Women with contraindication of induction of labour Women with previous caesarean section or uterine surgery
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol tablet, PGE2 gel<br>participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval. | Drug: Misoprostol<br>* Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses<br>* Other names: Misoprost;Drug: PGE2 gel<br>* PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses<br>* Other names: Dinoprostone gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean Section rate |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction delivery time |  | 48 hours | 
| Neonatal & maternal infectious morbidity |  | 14 days following date of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature rupture of membranes at term, Induction of labour, Misoprostol, PGE2 gel, Immediate induction with PGE2 gel, Immediate induction with Misoprostol
Syngo NATIVE Contrast Enhanced 3D MRA on 3T Verio Magnet

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare non-contrast abdominal MR Angiogram (MRA) syngo NATIVE sequence performed on a 3T Verio Siemens magnet to a standard contrast-enhanced MRA performed as part of routine clinical care in patients with normal renal function to determine if the non-contrast NATIVE sequence is a viable alternative to contrast enhanced MRA in patients with renal insufficiency. There are no interventions--this is an observational study.

Detailed Description
-----------------
If the NATIVE sequence proves to be a viable alternative to contrast enhanced MRA it will provide imaging physicians with the diagnostic tool to assess vascular disease in patients with renal insufficiency without placing them at risk for additional co-morbidities.

Official Title
-----------------
NATIVE Sequence for Non-Contrast MR Angiogram Compared With Conventional Contrast Enhanced 3D MRA on 3T Verio Magnet

Conditions
-----------------
Vascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over age 18 Signed informed consent Referred for standard of care MRA Exclusion Criteria: No contra-indications for MRI/MRA ie implants which could interfere with magnets Renal insufficiency which would preclude use of contrast-enhanced contrast for a standard of care MRA

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 |
| --- | --- |
| Syngo NATIVE MRA<br>All consenting participants will receive an additional non-contrast Syngo NATIVE MRA sequence prior to contrast injection their standard of care MRA. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of non-contrast enhanced MRA sequence | Compare non-contrast enhanced MRA images with contrast-enhanced MRA images. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRA, Syngo Native, Gadolinium, Non contrast
Retinal Function in Relation to Long Term Changes in the Glucose Level

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Insulin pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age >17 < 60 years Exclusion Criteria: Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Diabetic individuals<br> | Other: Insulin pump<br>* Patients receive an insulin pump that optimizes their glucose control.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT |  | 1 week, 1 month, 4 months, 1 year |
Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Monocentric study in University Hospitals Leuven (campus Gasthuisberg). Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements. Some demographic and obstetric parameters will be collected as well. The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.

Official Title
-----------------
Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women

Conditions
-----------------
Medication and Supplement Use During Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Number of registered medicines and supplements in hospital medical records of Belgian pregnant women |  | Hospital medical records from 11 months before delivery until 1 month postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmaceutical preparations, Dietary supplements
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance

Study Overview
=================
Brief Summary
-----------------
To observe the effect of PEEP on CVP among patients with different respiratory compliance

Detailed Description
-----------------
30 patients with mechanical ventilation and inserted central venous line will be entered. After gathering demographic data, patients undergone 5,10 and 15cmH2O PEEPs and the respective CVPs of the mentioned points will be recorded. According to the change of CVP, the patients will be divided into high response group and low response group, then comparing the lung compliance and thorax elastic resistance differences between the two groups.

Official Title
-----------------
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance

Conditions
-----------------
Sepsis, ARDS, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: 5,10 and 15cmH2O positive end expiratory pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients with mechanical ventilation and inserted central venous line Exclusion Criteria: The age is less than 18 years old or more than 80 years old； Pregnant and lying-in woman； Patients undergoing fluid resuscitation and the speed is more than 200ml/h； Patients with norepinephrine dose are greater than 15 micro per minute； Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation； Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high response group<br>patients undergo 5,10 and 15cmH2O positive end expiratory pressure ,the change of central venous pressure is more than 2.5cmH2O | Other: 5,10 and 15cmH2O positive end expiratory pressure<br>* every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points<br>|
| Placebo Comparator: low response group<br>the change of CVP is less than 2.5cmH2O | Other: 5,10 and 15cmH2O positive end expiratory pressure<br>* every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVP | Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O. | half an hour |
Rerouting Seton Versus LIFT for Complex Anal Fistula

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the efﬁcacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.

Official Title
-----------------
External Anal Sphincter-Sparing Seton After Rerouting Versus Ligation of Intersphincteric Fistula Tract (LIFT) In Treatment Of Complex Anal Fistula: A Randomized Clinical Trial

Conditions
-----------------
Anal Fistula

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female Exclusion Criteria: Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas. ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients Patient with any grade of anal incontinence. Patients with concomitant anal pathology.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rerouting seton<br>Placement of seton with rerouting of the fistula tract around the internal anal sphincter | Procedure: Rerouting seton<br>* Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter<br>|
| Active Comparator: LIFT<br>Ligation of the intersphincteric fistula tract | Procedure: LIFT<br>* Ligation of the intersphincteric fistula tract<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Healing of anal fistula | Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge | 12 months after surgery |
Morphology of the VMO in Patients With PFPS and Healthy Young Adults--A Sonographic Study

Study Overview
=================
Brief Summary
-----------------
Background：Patellofemoral pain syndrome（PFPS） is a common knee disorder characterized by anterior or retropatellar pain associated with activities that load the patellofemoral joint. Previous studies reveal that the vastus medialis obliquus（VMO） is an important dynamic medial stabilizer of the patellar. Insufficiency of the VMO leads to lateral shift of the patella and the increases the patellofemoral contact force. An in vitro study conducted by Hubbard JK. et al. claimed that there were no significant relationship between several morphologic characteristics of the VMO and the extent of patellofemoral joint deterioration. We consider that the condition might be different in vivo, so we chose ultrasonogrphy as the measurement tool to examine the morphology of the VMO in PFPS patients and healthy controls. Purpose：To determine if there are significant differences in several morphologic parameters of the VMO between patients with PFPS and healthy controls under 50. Method：31 PFPS patients and 31 matched healthy adults under 50 were recruited for the study. The HDI 5000 ultrasonography machine was used to evaluate morphologic parameters of the VMO, including the percent of patella attachment, fiber angle, the volume attached to the patella, and the change of shape of the VMO.

Official Title
-----------------
Morphology of the Vastus Medialis Obliquus in Patients With Patellofemoral Pain Syndrome and Healthy Young Adults --A Sonographic Study

Conditions
-----------------
Patellofemoral Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: under 50 years old. Have a diagnosis of PFPS. Exclusion Criteria: Diagnosis other than PFPS，such as meniscal lesion, ligamentous instability ,patellar tendon pathology, traction apophysitis, radiation pain, referred pain, ect. Knee operation within three month. X-ray findings (1)joint space narrowing (2)osteophyte formation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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 |
| --- | --- | --- |
Omentectomy in Radical Gastrectomy for Gastric Cancer Trial

Study Overview
=================
Brief Summary
-----------------
In patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases operation time significantly, especially in laparoscopic procedures. Patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. Furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. In the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.

Official Title
-----------------
Omentectomy in Radical Gastrectomy for Gastric Cancer Trial

Conditions
-----------------
Omentum, Stomach Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an in potentially curative gastric cancer age > 18 year Exclusion Criteria: palliative resection age < 18 year

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 |
| --- | --- | --- |
| tumorload in the greater omentum |  | at the time of pathologic investigation |
Characterizing Malignant Tumors Using Ultrasound Doppler Imaging

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether Ultrasound Doppler imaging can identify malignant tumors at a very early stage.

Official Title
-----------------
Characterizing Malignant Tumors Using Ultrasound Doppler Imaging

Conditions
-----------------
Malignant Tumor of Women's Reproductive System

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women presenting for routine abdominal/vaginal ultrasound Exclusion Criteria: Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with malignant tumor<br>Women with malignant tumor in reproductive system | Device: Ultrasound<br>* Ultrasound imaging of women arriving at clinic for routine care<br>|
| Women with benign tumor<br>Women with benign tumor in reproductive system | Device: Ultrasound<br>* Ultrasound imaging of women arriving at clinic for routine care<br>|
| Women with no observed tumor<br>Women with no observed tumor in reproductive system | Device: Ultrasound<br>* Ultrasound imaging of women arriving at clinic for routine care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early characterization of malignant tumors | Comparison of Ultrasound Doppler findings at different speeds between women without tumors, with benign tumors and with malignant tumors of reproductive system | One year |
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study

Study Overview
=================
Brief Summary
-----------------
To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.

Detailed Description
-----------------
This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control. The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units. Patients will be followed for a nine months period of time.

Official Title
-----------------
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study

Conditions
-----------------
Androgenic Alopecia

Intervention / Treatment
-----------------
* Device: ARTAS System
* Other: Manual Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI; Subject is 29 to 70 years old; Subject has black or brown hair color; Subject has straight hair; Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation; Subject agrees to have 6 dot tattoos placed on scalp; Subject is able to understand and provide written consent; and Subject consents to post-operative follow-up per protocol. Exclusion Criteria: Subject has prior history of scalp reduction surgery(s); Subject has prior history of hair restoration procedure(s) using the strip excision technique; Subject has bleeding diathesis; Subject has active use of anti-coagulation medication; Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study; Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARTAS System<br>Implantation with the ARTAS System. | Device: ARTAS System<br> <br> |
| Active Comparator: Manual Implantation<br>Implantation manually. | Other: Manual Implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Survival rate 9-months post procedure | Hair survival rate | 9 month |