linjc16/ctgov huggingface dataset:
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Study Overview
=================
Brief Summary
-----------------
Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.

Official Title
-----------------
Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease

Conditions
-----------------
Hyperparathyroidism, Secondary, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: doxercalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 5 Chronic Kidney Disease Hyperparathyroidism (PTH>300) requiring vitamin D therapy Age 18-80 years old Ability to provide informed consent Exclusion Criteria: Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy Subjects with contraindications or allergy to vitamin D Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days Serum phosphorus > 6 Serum calcium > 10.5 contraindications to nitroglycerin (such as being on sildenafil)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre and post doxicalciferol<br>ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive will receive doxercalciferol 2 mcg or 4 mcg 3 times per week fopr 30 days (1 month). Blood work and vascular laboratory studies will be performed pre and post treatment. | Drug: doxercalciferol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endothelial Cell Function | Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days. | 1 month |
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.

Official Title
-----------------
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating, Intravenous Doses Of RN316 (PF-04950615) In Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: RN316


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive. Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl. BMI 18.5 to 35, and body weight ≤150 kg, inclusive. Exclusion Criteria: Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results. Secondary hyperlipidemia. Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RN316<br> | Biological: RN316<br>* Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects |  | Entire duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects |  | Entire duration of study | 
| pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects |  | Entire duration of study | 
| single dose immunogenicity |  | Entire duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615
Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the usefulness of the new Ambu® aScope ™ 4 bronchoscope, in the usual practice of low complexity diagnostic bronchoscopy managed by bronchoscopists who meet the minimum training requirements (having performed 100 supervised procedures [ 10]) and maintenance of competition (with more than 25 bronchoscopies per year [10]).

Detailed Description
-----------------
Muticentric trial to evaluate three outcomes Describe the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4. Collect the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire. Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope.

Official Title
-----------------
Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4

Conditions
-----------------
Bronchoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study Exclusion Criteria: No acceptance of the informed consent Any procedure out of a low complexity bronchoscopy in the sites of the study

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 |
| --- | --- |
| Bronchoscopic procedures<br>Bronchoscopies performed in different sites to evaluate the level of satisfaction of the operators with the device Ambu® aScope™ 4 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoscope Quality questionnaire evaluation | - A numeric scale describes the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4. | Feb 2018- july 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Opinion of the operator -Quality of the sample | 1.A numeric scale collects the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire. | Feb 2018 -july 2018 | 
| - Sample quality | 2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield. | Feb 2018- july 2018 |
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.

Official Title
-----------------
Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study

Conditions
-----------------
Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Intervention / Treatment
-----------------
* Device: AutoLap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated Informed Consent Form (ICF). Patients over 18 years Exclusion Criteria: Pregnancy Extensive adhesions that will preclude routine laparoscopic surgical approach. American Society of Anesthesiologists' (ASA) classification>2

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The AutoLap system<br>Use of the AutoLap system for controlling the laparoscope during the procedure | Device: AutoLap<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful Follow Me movements |  | during surgery | 
| System set-up time |  | during surgery | 
| Length of procedure |  | during surgery | 
| Number of times that the laparoscope was removed for cleaning |  | during surgery | 
| AutoLap evaluation questionnaire |  | post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System repositioning |  | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic Cholecystectomy, laparoscope holder, gynecological laparoscopy procedures, fundoplication surgery, laparoscopic adnexal surgery, excision of endometriosis lesion, diagnostic laparoscopy procedures, right hemicolectomy, Diaphragmatic hernia
Single Incision Laparoscopic Appendectomy in the Community Utilizing Conventional Instruments

Study Overview
=================
Brief Summary
-----------------
There is a move to scarless surgery and this achieved by doing laparoscopic abdominal surgery though a single small umbilical incision. A technique for laparoscopic appendectomy done through a single incision utilizing conventional instruments has been developed. The operative risk of the single incision approach is no different that the standard three incision laparoscopic appendectomy. The goal is to study the operative time, length of hospital stay, and complications from this operation.

Official Title
-----------------
Single Incision Laparoscopic Appendectomy in the Community Utilizing Conventional Instruments

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: Single Incision Laparoscopic Appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing appendectomy for acute appendicitis Exclusion Criteria: pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Procedure: Single Incision Laparoscopic Appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar

Study Overview
=================
Brief Summary
-----------------
Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar

Detailed Description
-----------------
Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.

Official Title
-----------------
Clinical Study on Efficacy and Safety of Platelet Rich Plasma Combined With Laser for Scar Treatment

Conditions
-----------------
Acne Scar

Intervention / Treatment
-----------------
* Procedure: fractional carbon dioxide laser with platelet rich plasma
* Procedure: fractional carbon dioxide laser with NS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe acne scar Exclusion Criteria: taken procedures for acne scar within 6 months underlying diabetes mellitus, keloid, or malignancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fractional CO2 laser with PRP<br>fractional carbon dioxide laser followed by intradermal injection of platelet rich plasma | Procedure: fractional carbon dioxide laser with platelet rich plasma<br>* fractional carbon dioxide laser followed by platelet rich plasma injection<br>* Other names: COFRAX with autologous PRP;|
| Active Comparator: fractional CO2 laser with NS<br>fractional carbon dioxide laser followed by intradermal injection of NS | Procedure: fractional carbon dioxide laser with NS<br>* fractional carbon dioxide laser followed by normal saline injection<br>* Other names: COFRAX with normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of acne scar | 5-point grading of acne scar | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECCA (échelle d'évaluation clinique des cicatrices d'acné) | quantitative analysis of acne scar | 12 weeks | 
| adverse effect assessment | adverse effect assessment - erythema index, Epithelization Scale (0-12 point) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne scar, fractional carbon dioxide laser, platelet rich plasma
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa

Study Overview
=================
Brief Summary
-----------------
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.

Detailed Description
-----------------
It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.

Official Title
-----------------
Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence

Conditions
-----------------
Surgical Treatment of Urge Incontinence

Intervention / Treatment
-----------------
* Procedure: TOT
* Drug: solifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prior vasa or cesa operation as part of the URGE I study stress urinary incontinence mixed urinary incontinence Exclusion Criteria: previous urogynecological surgery avulsion of cesa or vasa tape pregnancy neurologic/psychological reasons for incontinence body weight >100kg syndrome of dry overactive bladder

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trans obturatorial tape (TOT)<br>placement of a sub-urethral tape | Procedure: TOT<br> <br> * Other names: trans obturatorial tape;|
| Active Comparator: solifenacin<br>10 mg per day | Drug: solifenacin<br> <br> * Other names: VESICUR 10mg per day;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure of incontinence |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of urge symptoms |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urge urinary incontinence, cesa, vasa, TOT, solifenacin
French Observatory of Familial Hypercholesterolemia in Cardiology

Study Overview
=================
Brief Summary
-----------------
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk. The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management. Main objectives: Establish a monitoring patients with hypercholesterolemia Family cardiology in France Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.

Official Title
-----------------
French Observatory of Familial Hypercholesterolemia in Cardiology

Conditions
-----------------
Familial Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary patients who agreed to participate high LDL-c levels: * LDL-c> = 1.9g / l without lipid lowering treatment according to the diagnostic score of Family Hypercholesterolemia these coronary patients with LDL> 1.9g / l may possibly or probably be achieved Hypercholesterolemia Family. or * LDL-c> = 1.6g / l in lipid-lowering treatment, the reduction of LDL-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved Family Hypercholesterolemia after the diagnostic score. Exclusion Criteria: Expressed refusal to participate in the observatory Age ≤ 18

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 |
| --- | --- |
| Family Hypercholesterolemia in cardiology<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of the Family Hypercholesterolemia in cardiology | Number of Family Hypercholesterolemia among patients with LDL-C> 1.9g / l without hypoglycemic treatment or> 1.6g / l in lipid-lowering therapy | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiology, Family Hypercholesterolemia
Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

Study Overview
=================
Brief Summary
-----------------
Capillary or venous lactate level evaluation in prehospital care could be simple and beneficial tool for optimising prehospital care in patients with severe trauma.

Detailed Description
-----------------
Evaluation of blood lactate level and its trend are important morbidity and mortality predictive factors. In prehospital care, lactate level is more sensitive marker and have better prognostic value in severe trauma than basic vital signs. Worse outcome is associated with levels between 2 - 4 mmol/l. Measurement of lactate level in venous or capillary blood is quick and simple method with minimal risks and with no special needs for medical staff training. In spite of good availability of this method in the Czech Republic the method feasibility has never been analysed in patients with severe trauma.

Official Title
-----------------
Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma

Conditions
-----------------
Trauma, Multiple, Lactate Blood Increase

Intervention / Treatment
-----------------
* Procedure: capillary and venous lactate level measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient having / suspected to have severe trauma treated by cooperating Emergency Medical System organization Exclusion Criteria: possible alterations of plasma lactate level in the time of trauma (seizure, malignity, use of beta-2 agonists, severe liver and/or kidney failure, ketoacidosis, intoxication)

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 |
| --- | --- |
| Trauma patients<br>All patients having / suspected to have severe trauma injuries | Procedure: capillary and venous lactate level measurement<br>* capillary and venous lactate level measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of lactate level measurement | Proportion of subjects with measured and recorded prehospital lactate level | 1 day - the time the patient is treated by Emergency Medical System |