linjc16/ctgov huggingface dataset:
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System

Study Overview
=================
Brief Summary
-----------------
To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System

Detailed Description
-----------------
The purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System.

Official Title
-----------------
A Multi-Center Prospective Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System

Conditions
-----------------
Trauma, Tumor, Pseudarthrosis, Scoliosis, Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: VueLock™ Anterior Cervical Plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion. The patient must be available for follow-up during the study. The patient must be skeletally mature (epiphyses closed). Exclusion Criteria: Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc. Pregnant or nursing females. Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VueLock™ Anterior Cervical Plate Group<br>VueLock™ Anterior Cervical Plate, Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion) | Device: VueLock™ Anterior Cervical Plate<br>* Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients with radiographic fusion |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline |  | 24 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Degenerative Disc disease (DDD)
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis to be tested is: The detection of breast cancer will be increased with tomosynthesis (3D) imaging

Detailed Description
-----------------
The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

Official Title
-----------------
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Tomosynthesis
* Device: Conventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Any ethnic origin No contraindication for routine bilateral mammography Exclusion Criteria: Potential subjects with any of the following will not be enrolled in the study: Any contraindications to mammographic screening, including, but not limited to: Significant existing breast trauma Under the age of 30 at the time of consent Breast Implants Prior Surgeries Unable to understand and execute written informed consent Pregnant Lactating

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional + Tomosynthesis<br>conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later. | Device: Tomosynthesis<br>* The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).<br>Device: Conventional<br>* conventional (2D) imaging (standard mammography)<br>|
| Active Comparator: Tomosynthesis alone<br>tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later. | Device: Tomosynthesis<br>* The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Breast Cancer (Sensitivity) | Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN) | up to two years follow up for development of breast cancer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, imaging
Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment

Study Overview
=================
Brief Summary
-----------------
Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.

Official Title
-----------------
Syringeable Atorvastatin Loaded Eugenol Enriched PEGylated Cubosomes In-situ Gel for the Intra-pocket Treatment of Periodontitis: Statistical Optimization and Clinical Assessment

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Drug: Atorvastatin Calcium
* Drug: Atorvastatin Calcium
* Other: Scaling and debridement only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemically healthy patients Patients with moderate periodontitis Exclusion Criteria: Pregnant women Lactating women Patients with chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phase 1 therapy<br> | Other: Scaling and debridement only<br>* Scaling and debridement only<br>|
| Active Comparator: Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel<br> | Drug: Atorvastatin Calcium<br>* Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement<br>|
| Active Comparator: Phase 1 therapy with atorvastatin loaded into in-situ gel<br> | Drug: Atorvastatin Calcium<br>* Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth |  | 6 weeks | 
| Bleeding index |  | 6 weeks | 
| Plaque index |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of transforming growth factor in gingival crevicular fluid |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontitis, Non-surgical treatment, Atorvastatin, Phase 1 therapy
Anti-Platelet Drugs and Brain-derived Neurotrophic Factor (BDNF) in Human Serum and Plasma

Study Overview
=================
Brief Summary
-----------------
The impact of anti-platelet drugs on the concentrations of Brain-derived neurotrophic factor (BDNF) in human plasma and serum is unknown. It is the aim of this study to investigate the impact of a single dose of Aspirin (500 mg) or Clopdigrel (600 mg) on the concentrations of Brain-derived neurotrophic factor (BDNF) in plasma and serum of healthy volunteers.

Official Title
-----------------
The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Aspirin and Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 years Gender: Male Exclusion Criteria: Any acute disease Any chronic disease Any medication Allergies / Intolerance in association with Aspirin or Clopidogrel

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: A<br>Intake of 500 mg Aspirin on day 1. Intake of 600 mg Clopidogrel on day 28. Measurement of platelet inhibition, platelet counts and BDNF, TGF-beta, 5-HT concentrations in peripheral blood on day 1 (before intake of 500 mg Aspirin), day 2 (24 hours after intake of 500 mg Aspirin), day 28 (before intake of 600 mg Clopidogrel), day 29 (24 hours after intake of 600 mg Clopidogrel). | Drug: Aspirin and Clopidogrel<br>* Intake of 500 mg Aspirin on day 1. Intake of 600 mg Clopidogrel on day 28. Blood collection for the measurement of platelet inhibition, platelet counts and BDNF, TGF-beta, 5-HT concentrations in peripheral blood on day 1 (before intake of 500 mg Aspirin), day 2 (24 hours after intake of 500 mg Aspirin), day 28 (before intake of 600 mg Clopidogrel), day 29 (24 hours after intake of 600 mg Clopidogrel).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain-derived neurotrophic factor (BDNF), Platelets, Aspirin, Clopidogrel
Sexuality Education: Knowledge of Women Aged 18 to 25

Study Overview
=================
Brief Summary
-----------------
Information, education and communication concerning sexual health are essential for enable to do informed and responsible decisions about it. In France, education for sexuality in schools still remains unequal and is considered as unsuited to the realities of young people. This observation led to the development of a national sexual health strategy. One of the challenges is to promote and enhance the implementation of interdisciplinary sexuality education. Midwives are and should be involved in the issue of sexuality.

Detailed Description
-----------------
The aim of the study is to describe knowledge concerning sexuality of young women aged 18 to 25.

Official Title
-----------------
Sexuality Education: Knowledge of Women Aged 18 to 25

Conditions
-----------------
Sexual Behavior

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female aged 18 to 25 years old with or without sexual activity agreeing to participate in the study Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 aged 18 to 25 group<br>women aged 18 to 25 group: women aged 18 to 25 with or without sexual activity | Other: Data collection<br>* evaluation of women's knowledge concerning sexuality<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge about clitoris | knowledge about the clitoris functions: reproduction (yes/no), sexual pleasure (yes/no), urinary finction (yes/no) and childbirth (yes/no) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual health well-being | Personal sexual fulfillment evaluated using a Likert scale (from not at all to totally) | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexuality, knowledge, young women, education
Characterization of Phenotype and Genotype of Early Onset Enteropathies

Study Overview
=================
Brief Summary
-----------------
This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies. In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.

Detailed Description
-----------------
This study specifically aims at the genetic analysis of early onset enteropathies with the goal in mind to delineate human pathways necessary to maintain intestinal homeostasis despite the considerable density of microbes colonizing the distal part of the human intestine.

Official Title
-----------------
Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Other: Biological sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Severe chronic enteropathy Patients developing their first symptoms within the first 6 years of life and, in priority within the first two years of life, or patients with a disease of later onset, in case of a familial history suggestive of inherited mutations notably in families comprising several affected members OR : Be a patient's relative, even if presenting with enteropathy of later onset. Main Exclusion Criteria: Subject having participated to any therapeutical clinical study in the 30 days preceding the inclusion in this study,
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sick patients<br>Biological sampling of blood for all patients. Biological sampling of saliva, biopsies (skin and endoscopic), feces, for some patients | Other: Biological sampling<br>* Biological sampling including blood, feces, biopsies...<br>|
| Healthy relatives<br>Biological sampling of blood for all healthy relatives | Other: Biological sampling<br>* Biological sampling including blood, feces, biopsies...<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increasing the current rate (20%) of genetic characterization of early onset entheropathies | Currently, around 20% of early onset entheropathies are genetically characterized. Investigators want to increase this rate via this research protocol. Our long term objective is to characterize phenotypes and genotypes of patients with early onset enteropathies. | 40 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early Onset Entheropathy
Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectomy Surgery and Controls

Study Overview
=================
Brief Summary
-----------------
Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.

Detailed Description
-----------------
Approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. Scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.

Official Title
-----------------
Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectony Surgery and Controls

Conditions
-----------------
Nuclear Sclerotic Cataract

Intervention / Treatment
-----------------
* Procedure: Scheimpflug crystalline lens photographs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: phakic eyes of patients that are scheduled to undergo pars plana vitrectomy, controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery, age 18 and older Exclusion Criteria: any eye that is pseudophakic, has had previous vitreoretinal surgery, has had previous intravitreal injection, previous intraocular inflammatory condition such as uveitis, previous irradiation, any patient with a history of ocular malignancy, history of infectious intraocular condition

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Scheimpflug crystalline lens photographs|scheimpflug photographs|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, nuclear sclerotic cataract
Treatment of Acne Scarring With a Novel Procedure Combination

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.

Detailed Description
-----------------
The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.

Official Title
-----------------
The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance

Conditions
-----------------
Acne Scarring

Intervention / Treatment
-----------------
* Procedure: subdermal manipulation ONLY
* Procedure: subdermal manipulation AND injection of a filler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and over Have two acne scar areas The subjects are in good health The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Exclusion Criteria: Under 18 years of age Pregnancy or Lactation Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>scars receive subdermal manipulation ONLY | Procedure: subdermal manipulation ONLY<br>* scars receive subdermal manipulation ONLY<br>* Other names: subcision;|
| Experimental: B<br>scars receive subdermal manipulation AND injection of a filler | Procedure: subdermal manipulation AND injection of a filler<br>* scars receive subdermal manipulation AND injection of a filler<br>* Other names: Radiesse;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Improvement |  | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 3.5 months |