linjc16/ctgov huggingface dataset:
Genetic Variability in Taste Perception

Study Overview
=================
Brief Summary
-----------------
This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.

Detailed Description
-----------------
This is a cross-sectional call-back study of taste perception and the relationship between taste perception and taste receptor genotype.

Official Title
-----------------
Genetic Variability in Taste Perception

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789) Exclusion Criteria: Women who are pregnant Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysical data for taste solutions | Primary outcome variables are intensity ratings of pediatric medications as well as a variety of generally recognized as safe bitter and non-bitter compounds. | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal practices and perceptions of medication use | Secondary outcome variables include questions related to maternal practices and perceptions of medication use and compliance of their children. | 1-2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bitter Taste, Pediatric Medications
Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.

Official Title
-----------------
Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery

Conditions
-----------------
Femoral Artery Injury, Aortic Valve Insufficiency

Intervention / Treatment
-----------------
* Other: Data collect


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject voluntarily agreeing to participate in the study Subject >= 18 years of age Patients operated between december 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital Patients in whom the MANTA device has been used for femoral artery closure Exclusion Criteria: Not applicable

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 |
| --- | --- |
| Patients operated from minimally invasive cardiac surgery<br>Patients operated between December 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University hospital and in whom the MANTA device has been used for femoral artery closure | Other: Data collect<br>* Data collect following a vascular closure by MANTA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of major access site vascular complications | according to the Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC)-2 definition criteria in postoperative period | 30 days | 
| Hemostasis success | Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding | 10 min |
Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.

Conditions
-----------------
Hallux Valgus

Intervention / Treatment
-----------------
* Device: CyclaPlex Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight less than 100 kilos IMA greater than 12 degrees IMA less than 7 degrees Exclusion Criteria: Diabetics Known osteoporosis Known allergy or hypersensitivity to metals Gout or any systemic inflammatory arthropathy

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyclaPlex Implant<br>Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy. | Device: CyclaPlex Implant<br>* Button and suture type implant that will be implanted between the first and second metatarsal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMA Reduction | The IMA angle is measured pre-op and post-op on x-ray images using internal software. The IMA at end of study should be less than 10 degrees or a reduction of more than 5 degrees. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopedic Foot and Ankle Society (AOFAS) Score | General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score | One year |
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.

Official Title
-----------------
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Biological: Intra-articular injection of SVF plus PRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients age 50 or older who present with symptomatic primary osteoarthritis of the knee daily pain for the previous 3 months analgesics usage at least once a week less than 30 minutes of morning stiffness WOMAC score of ≤ 75 in the target knee Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2 Exclusion Criteria: evidence of secondary knee osteoarthritis severe osteoarthritis (Joint space width - JSW < 2 mm) prior intra articular injections within the previous one year prior to inclusion patients with clinically significant systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: SVF and PRP<br> | Biological: Intra-articular injection of SVF plus PRP<br>* administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC (Western Ontario and McMaster Universities Arthritis Index) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk distance |  | 1 year |
Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.

Official Title
-----------------
Does Specific Immunotherapy Possess Immunomodulative Effects at the Bronchial Mucosa Level Among Adults With Atopic Diseases?

Conditions
-----------------
Asthma, Bronchial, Allergic Rhinitis, Hypersensitivity, Immediate

Intervention / Treatment
-----------------
* Biological: Specific immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 years old Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy Exclusion Criteria: Other diseases except atopic disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Specific immunotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin prick test |  |  | 
| Spirometry |  |  | 
| Methacholine provocation of the pulmonary system |  |  | 
| Exhaled nitric oxide |  |  | 
| Immunoglobulin E (IgE) status |  |  | 
| Sputum examination |  |  | 
| Condensation of exhaled air |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Allergic rhinitis, Atopy, Exhaled nitric oxide, Specific immunotherapy, Atopic diseases
Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length

Study Overview
=================
Brief Summary
-----------------
Accurate length determination of root canal is essential in root canal therapy. Radiography has been the conventional method for this measurement but recently several in-vitro studies have shown that new generations of Electronic Apex locators are as accurate as radiography in length determination. It is hypothesized that the latest generation of Electronic Apex locator can produce acceptable results as radiography when used for length determination.

Official Title
-----------------
Clinical Evaluation of Working Length Determination by Electronic Apex-Locator or Radiography on Adequacy of Final Working Length

Conditions
-----------------
Root Canal

Intervention / Treatment
-----------------
* Device: Electronic Apex Locator
* Device: Dental Radiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients who are referred for Root Canal Therapy Exclusion Criteria: Blocked Canals Open Apexes

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apex Locator<br>Working length for cleaning and shaping of the canal is measured by Electronic Apex Locator in this group. | Device: Electronic Apex Locator<br>* Electronic Apex Locator is used to find the apical foramen of the root canal. It uses a weak electrical current passed through the canal by endodontic file.<br>* Other names: Raypex;|
| Active Comparator: Radiography<br>Working length for cleaning and shaping of the canal is measured by Radiography in this group. | Device: Dental Radiography<br>* Radiography is used to measure the length of root canal by putting an endodontic file in the canal and taking the radiography to measure the length.<br>* Other names: pre apical Radiography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequacy of final working length |  | at the end of cleaning and shaping | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Length Determination, Working Length, Electronic Apex Locator, Root Canal Therapy, Endodontics
ENRED@TE. Social Support in Southern Spain. Interventional Study

Study Overview
=================
Brief Summary
-----------------
The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).

Official Title
-----------------
ENRED@TE. Social Support in Southern Spain. Interventional Study

Conditions
-----------------
Social Isolation

Intervention / Treatment
-----------------
* Behavioral: ENRED@TE: Behavioural multicomponent intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People over 65 years Not institutionalised Exclusion Criteria: Participants of other programs Difficulty responding to measurement scales due to language barriers Legal incapacitation People with a residence of less than 3 months in the city

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Behavioural multicomponent intervention | Behavioral: ENRED@TE: Behavioural multicomponent intervention<br>* Information and awareness activities; activities for the acquisition of skills; activities that help the elderly to attend spaces for leisure, participation and maintenance and/or improvement of their personal relationships.<br>|
| No Intervention: Control group<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social isolation | Duke-UNC Functional Social Support Questionnaire (Bellón et al. 1996) is an eight-item instrument to measure the strength of the person's social support network. Each item is ranged from 1 to 5 points, where high scores represent greater social support. | 6 months | 
| Loneliness | UCLA Loneliness Scale (Russell DW, 1996) which is a 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. This tool use a 4-point rating scale (1= never; 4 = always). High values mean more loneliness. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of risk situations or social problems | Gijón socio-family assessment scale (García González et al. 1999) allows the detection of risk situations or social problems. Values range from 3 to 15. Higher values mean more severe social decline. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social isolation, Social support, Loneliness, Family support
Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation

Study Overview
=================
Brief Summary
-----------------
In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics Unit. Pharmacodependence notifications issued by professionals are collected by each Centre which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as each CEIP had his own way of analysing his cases. The aim of this study is to assess this tool.

Official Title
-----------------
Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation

Conditions
-----------------
Drug Abuse, Drug Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pharmacodependance cases<br>Case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine . |  | At the beginning of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug and substance problematic use, abuse or dependence
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.

Official Title
-----------------
Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions

Conditions
-----------------
Wound Infection

Intervention / Treatment
-----------------
* Procedure: Vicryl Suture
* Device: 3M TM S Surgical Skin Closure System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing mediastinotomy for cardiac surgical procedures Exclusion Criteria: Patients with: Allergies to skin adhesives Known keloid formation Prior sternotomies Conditions making them not candidates for vicryl skin closure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: 1 Vicryl Suture<br>Patients will have their incision closed with vicryl suture | Procedure: Vicryl Suture<br>* A 4-0 vicryl suture will be used to close the subcuticular layer<br>|
| Experimental: 2 Steri-Strips<br>Patients will have their incisions closed with 3M Surgical-Strips | Device: 3M TM S Surgical Skin Closure System<br>* These steri-strips will be applied to close the skin in this cohort of patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of erythema |  | 30 days following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection |  | 30 days following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sutures