linjc16/ctgov huggingface dataset:
Glycocalyx During Normothermic Machine Perfusion

Study Overview
=================
Brief Summary
-----------------
An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs. It is known from numerous studies that the integrity of the endothelial glycocalyx is necessary for organ function. Normothermic machine perfusion is an alternative storage method for explanted livers, where the graft is perfused with warm blood. This study aims to clarify the influence of normothermic machine perfusion on endothelial glycocalyx damage of the graft.

Official Title
-----------------
Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study

Conditions
-----------------
Glycocalyx, Liver Transplantation

Intervention / Treatment
-----------------
* Diagnostic Test: Heparansulfate and Syndecan 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First deceased donor liver transplantation receiving a graft after normothermic machine perfusion Recipient age >18 years Written informed consent Exclusion Criteria: Age < 18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normothermic Machine Perfusion<br>Blood sampling at 5 time points after transplantation Perfusate collection at 3 time points during normothermic machine perfusion prior to transplantation | Diagnostic Test: Heparansulfate and Syndecan 1<br>* Blood samples will be collected from the patient at 5 different time points. Three perfusate samples will be collected during normothermic machine perfusion (4,9ml each).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syndecan 1 level during normothermic machine perfusion | Syndecan 1 level at the end of normothermic perfusion compared to the beginning of perfusion | 24 hours | 
| Heparansulfate level during normothermic machine perfusion | Heparansulfate level at the end of normothermic perfusion compared to the beginning of perfusion | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syndecan 1 after transplantation | Change of Syndecan 1 level after transplantation | 72 hours | 
| Heparansulfate level after transplantation | Change of Syndecan 1 level after transplantation | 72 hours |
Endometriosis of the Recto-sigmoid: MRI (Magnetic Resonance Imaging) Criteria Predictive of Shaving or Segmental Resection

Study Overview
=================
Brief Summary
-----------------
Evaluate MRI criteria predictive of the type of surgery to be performed for an in sano resection of endometriotic involvement of the recto-sigmoid by a resection without opening of the rectal mucosa (shaving) versus a segmental resection.

Detailed Description
-----------------
PURPOSE: To retrospectively determine the accuracy of MRI rectal and pararectal signs in predicting a segmental resection of lesions located in the rectum until the recto-sigmoid junction. MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 61 patients treated for rectal endometriosis over a 6 years period were reviewed. Two blinded readers performed in consensus a systematic analysis of 7 rectal (length, transverse axis, thickness and circumference of the lesion, and presence of a convex base, submucosal edema and hyperintense cystic areas) and 4 pararectal (posterior vaginal fornix, parametrial, ureteral and sacro-recto-genital septum involvements) signs for each lesion. MR imaging results were compared with surgical procedure (shaving versus segmental resection). Efficacy parameters were calculated with 95 % confidence intervals (CIs).

Official Title
-----------------
Endometriosis of the Recto-sigmoid: MRI Criteria Predictive of Shaving or Segmental Resection

Conditions
-----------------
Endometriotic Parietal Involvement of the Rectosigmoid

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operated patient for a pelvic endometriosis with resection without opening of the rectal mucosa (shaving) or with segmental resection of the recto-sigmoidienne. Performing a preoperative pelvic MRI with at least 2 perpendicular T2 planes Exclusion Criteria: Refusal to use clinical data and exploration acquired Absence of interpretable preoperative pelvic MRI

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

| Intervention/Treatment |
| --- |
|Other: MRI|MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of MRI data with intraoperative data and anatomopathology | MRI criteria of parietal involvement will be confronted with the type of surgery performed (shaving or segmental resection) A rectosigmoid parietal involvement will be defined by the nodular replacement of the normal signal of the digestive muscularis, on at least two planes of cuts or two different weightings. | Intraoperatively |
Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach

Study Overview
=================
Brief Summary
-----------------
This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods

Detailed Description
-----------------
Purpose: This study aims to perform statistical inference and prediction of changes in fetal heart rate during active labor in healthy pregnant women by comparing three different machine learning methods. Methods: A retrospective analysis of 1077 healthy laboring parturients receiving neuraxial analgesia was conducted. We compared a principal components regression model with treebased random forest, ridge regression, multiple regression, a general additive model, and elastic net in terms of prediction accuracy and interpretability for inference purposes.

Official Title
-----------------
Fetal Heart Rate Changes and Labor Neuraxial Analgesia: a Machine Learning Approach

Conditions
-----------------
Fetal Bradycardia

Intervention / Treatment
-----------------
* Procedure: Labor Neuraxial Analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years Pregnancy requiring labor analgesia Active labor Request of neuraxial analgesia per patient and/or obstetrician Received combined spinal-epidural technique Exclusion Criteria: Uterine tachysystole before neuraxial analgesia. Baseline blood pressure <90/60 mmHg. Third trimester hemorrhage Eclampsia Allergies to local anesthetics or fentanyl. Maternal fever. Pruritus before performance of neuraxial analgesia

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Labor Neuraxial Analgesia|Labor Neuraxial Analgesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal bradycardia | fetal heart rate under 120 lpm for more than 10 minutes | 15 minutes |
Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control

Study Overview
=================
Brief Summary
-----------------
Study is an observational study among hypertensive patients

Detailed Description
-----------------
Objective: To investigate drug adherence and lifestyle behaviors affecting the blood pressure (BP) control among hypertensive patients that have uncontrolled and controlled BP.

Official Title
-----------------
Pharmacological and Nonpharmacological Factors That Contribute Blood Pressure Control

Conditions
-----------------
Hypertension,Essential

Participation Criteria
=================
Eligibility Criteria
-----------------
Patient inclusion criteria were as follows: aged between 38 and 74 years, hypertension diagnosis history of at least 6 months use of at least one antihypertensive medication. Exclusion Criteria: -not willing to join the clinical trial

Ages Eligible for Study
-----------------
Maximum Age: 74 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 |
| --- | --- |
| controlled hypertension<br>Controlled hypertension was defined as systolic blood pressure (SBP) ≤139 mmHg and/or diastolic blood pressure (DBP)≤89 mmHg for non-diabetic patients, and as SBP ≤139 mmHg and/or DBP ≤84 mmHg for diabetic patients, based on the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) guidelines. observational study | |
| uncontrolled hypertensive patients.<br>Individuals who had blood pressure levels above these values were defined as uncontrolled hypertensive patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life. | EQ-5D-3L turkish validation test | at the time of the beginning of the study | 
| Age | years | at the time of the beginning of the study | 
| Gender | Female/Male | at the time of the beginning of the study | 
| BMI | (kg/m2) | at the time of the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complementary and alternative medicine use | subjective reports from patients (yes/no) | at the time of the beginning of the study |
Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension

Study Overview
=================
Brief Summary
-----------------
To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.

Detailed Description
-----------------
A comparison of oral labetalol and oral nifedipine for management of postpartum hypertension. Which drug is more effective in lowering blood pressures in patient with postpartum hypertension.

Official Title
-----------------
Comparison of Oral Labetalol and Oral Nifedipine for Postpartum Hypertension Management

Conditions
-----------------
Postnatal Hypertension

Intervention / Treatment
-----------------
* Drug: Labetalol
* Drug: Nifedipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all women with postpartum hypertension as a continuation of pregnancy induced hypertension,eclampsia, pre-eclampsia or new onset de-novo postpartum hypertension,of any parity. age group between 18-48. after informed consent. Exclusion Criteria: all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded. conditions in which drugs labetalol and nifedipine is contraindicated.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 48 Years

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

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

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 |
| --- | --- |
| Active Comparator: group A<br>tab.labetalol is given to the patient with postpartum hypertension in dose of 100 mg 6 hourly increased to maximum 600 mg in 24 hours | Drug: Labetalol<br>* anti-hypertensive agents<br>|
| Active Comparator: group B<br>tab.nifedipine is given to the patient with postpartum hypertension in the dose of 10 mg twice a day to maximum dose of 60 mg per 24 hours | Drug: Nifedipine<br>* calcium channel blocker ,for lowering blood pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure less than 140/90 mm of hg | less than 140/90 mm of hg | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum hypertension, labetalol in postpartum hypertension, nifedipine in postpartum hypertension
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Patients with mild to moderate dry eye disease will be randomized to receive either NovaTears® or Hydrabak® eye drops as control.

Official Title
-----------------
Influence of Perfluorohexyloctane (NovaTears) on Tear Film Thickness in Patients With Mild to Moderate Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Device: NovaTears®
* Device: Hydrabak®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged over 18 years History of dry eye disease for at least 3 months before the screening visit Be able and willing to follow instructions, including participation in all study assessments and visits Signed and dated written informed consent Exclusion Criteria: Have any clinically significant slit-lamp findings at the screening visit that may include trauma, Steven Johnson syndrome, and/or in the opinion of the investigator may interfere with study parameters Participation in a clinical trial in the 4 weeks preceding the before the screening visit Active ocular allergies or ocular allergies that are expected to be active during the study period Pregnancy, planned pregnancy or lactating Known hypersensitivity to any component of the study medication Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NovaTears®<br> | Device: NovaTears®<br>* Topical eye drops for lubrication of the ocular surface<br>|
| Active Comparator: Hydrabak®<br>Unpreserved sodium chloride (0.9%) eye drops in ABAK® system | Device: Hydrabak®<br>* Eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film thickness as measured with high resolution optical coherence tomography |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid layer thickness |  | 4 weeks | 
| Non-invasive tear break up time |  | 4 weeks | 
| Dynamic Meibomian Gland Imaging |  | 4 weeks | 
| Blink frequency |  | 4 weeks | 
| Symptom VAS |  | 4 weeks | 
| Corneal fluorescein staining |  | 4 weeks | 
| Conjunctival lissamine green staining |  | 4 weeks | 
| Schirmer I test |  | 4 weeks | 
| Tear film break up time |  | 4 weeks | 
| Ocular surface disease index |  | 4 weeks |
Influence of Periodontal Diseases on Vascular Parameters in Patients Suffering of Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the influence of the severity of chronic periodontitis on hemodynamic parameters in hypertensive patients.Secondary purposes of this protocol is to identify evolution of several biomarkers and correlate the clinical situation with oral microflora.

Official Title
-----------------
Influence of Periodontal Diseases on Hemodynamic and Molecular Vascular Parameters in Patients Suffering of Hypertension

Conditions
-----------------
Chronic Periodontitis, Hypertension

Intervention / Treatment
-----------------
* Other: echo Doppler lower limbs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Men- >40 years moderate and severe generalized chronic periodontitis Former diagnosis of hypertension >12 teeth Exclusion Criteria: >70 years smokers (>10 cig/day) body mass index>30 Need of antibioprophylaxis Medical treatment including anti-inflammatory drugs and/or antibiotics Refractory form of hypertension- aggressive periodontitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| blood and cardiological examination<br> | Other: echo Doppler lower limbs<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the thickness of the intima-media |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of anatomical changes that may occur at the arterial level |  | Within 15 days after inclusion |
Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization

Study Overview
=================
Brief Summary
-----------------
Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds. The investigators attempt to validate this long-standing statement.

Conditions
-----------------
Catheterization, Ipsilateral Nipple, Internal Jugular Vein

Intervention / Treatment
-----------------
* Procedure: SCM triangle - ipsilateral nipple


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients over the age of 18 undergoing general anesthesia Exclusion Criteria: history of neck or breast surgery anatomical anomaly of the neck or breast neck mass breast mass

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Traditional<br> | Procedure: SCM triangle - ipsilateral nipple<br>* draws the tract of the IJV using the SCM triangle head and the ipsilateral nipple<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in angle | difference in angle between traditional (triangular head of the SCM - ipsilateral nipple) and ultrasound guided tract | 1 day |
Immune Modulation From Trichuris Trichiura

Study Overview
=================
Brief Summary
-----------------
Mucosal immunology during helminth infection

Detailed Description
-----------------
The present study investigates the effects of Trichuris trichiura on human mucosal and systemic immunity in a single self-infected individual.

Official Title
-----------------
Mucosal and Systemic Immune Modulation From Trichuris Trichiura in a Self-infected Individual

Conditions
-----------------
Crohn Disease, Colitis, Ulcerative, Intestinal Helminthiasis

Intervention / Treatment
-----------------
* Biological: Trichuris trichiura eggs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy. Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trichuris trichiura eggs<br>One healthy volunteer | Biological: Trichuris trichiura eggs<br>* Live eggs from human whipworm, Trichuris trichiura<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal egg excretion | Weekly monitoring of fecal egg counts by microscopy | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal T cell associated cytokines | Biopsy sampling during established infection | Week 15 | 
| Systemic immune parameters (eosinophilia, Subtypes of circulating T cells) | Weekly monitoring | 30 weeks | 
| Adverse events | The included individual was monitored clinically every week for the development of diarrhea and weight loss, and by blood samples for anemia and inflammatory parameters every other week. | 30 weeks |