linjc16/ctgov huggingface dataset:
Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

Study Overview
=================
Brief Summary
-----------------
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity. The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.

Official Title
-----------------
Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery

Conditions
-----------------
Otorhinolaryngologic Diseases

Intervention / Treatment
-----------------
* Device: Mandibular prosthesis made of a new highly biointegratable material


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female more than 18 years old Exclusion Criteria: Age less than 18 years old Pregnant women Local carcinoma excluding radiotherapic or surgical control Poor general condition Contraindication to general anesthesia Uncontrolled diabetes

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mandibular prosthesis made of a new highly biointegratable material|Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEP scan + MRI + CT scan |  | 3 months after surgery | 
| Blood analysis (interleukin) |  | 8, 15, 30 days and 3 months after surgery | 
| All types of complication |  | 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Study Overview
=================
Brief Summary
-----------------
Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Detailed Description
-----------------
Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects. CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy. This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.

Official Title
-----------------
A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Conditions
-----------------
Hysteroscopic Adhesiolysis

Intervention / Treatment
-----------------
* Device: CollaGUARD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis Willing to use additional contraception throughout study Exclusion Criteria: Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study Has suffered or currently suffers from a gynaecological malignancy Has undergone a previous hysteroscopic surgery (such as removal of fibroids)

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

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

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 |
| --- | --- |
| Other: CollaGUARD<br> | Device: CollaGUARD<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire | surgeon completed questionnaire | following initial hysteroscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of de novo adhesion and adhesion reformation | assessed during follow-up hysteroscopy | 9 weeks post initial hysteroscopy | 
| Change in severity of adhesions | European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS) | 9 weeks post initial hysteroscopy | 
| Degradation of CollaGUARD | assessed via ultrasound | 2 weeks post initial hysteroscopy |
Entia Liberty: Home Study

Study Overview
=================
Brief Summary
-----------------
Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Participants will be asked to fill in interim questionnaires and a final questionnaire to answer the study objectives.

Official Title
-----------------
Entia Liberty: Home Study - Evaluation of Patient Preference for a Novel Full Blood Count Home Testing Device Versus Routine Venous Monitoring

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Entia Liberty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Adequate English language skills (not requiring a translator) to participate in participant training and use the Liberty device Patients willing and able to perform capillary blood self-testing at the same frequency as routine full blood count monitoring Patients capable of providing informed consent before attending training Patients able to attend a 1-hour virtual training session within 2 weeks of joining the study Patients with a home Wi-Fi network or with adequate coverage at home via a 4G network Patients with access to a laptop or smartphone to facilitate training Patients with a diagnosis of ovarian or breast cancer Patients whose HCPs can confirm are undergoing systemic anti-cancer treatments within two weeks of enrolment, with treatment expected to continue for at least two cycles Exclusion Criteria: Patients with haematological malignancies Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Liberty device or participation in training unless they have a nominated caregiver who is capable of assisting with each test

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 |
| --- | --- |
| Patient Group<br> | Device: Entia Liberty<br>* Home monitoring blood analyser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess patient preference for the Liberty self-testing pathway as compared to standard of care. | Patients will undergo the study procedures without change to their current pathway, at the end of the study, patients will compare the interventions via a SURVEY. The investigators will measure the success of the comparison by the % of patients who have chosen the investigators' product over the standard of care (4-5 rating out of 5). | 12 months |
Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

Study Overview
=================
Brief Summary
-----------------
This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes Weight Loss Co-morbid disease resolution

Official Title
-----------------
Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet the following criteria to be eligible for study entry: Age between 18 - 80 years, and Severely or Morbidly obese: BMI > 35, or BMI > 30 + co-morbid obesity related disease condition Without any contraindications to bariatric surgery, and Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.) Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain Exclusion Criteria: Subjects meeting the following criteria will be excluded from study entry: Any patient not meeting the inclusion criteria Patients with any major medical problems contraindicating surgery Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.) Patients who elect to undergo a surgery other than a PLAGB or SLAGB Pregnant or planning pregnancy within 12 months Alcohol or drug addiction Established infection anywhere in the body at the time of surgery Previous history of other bariatric surgery (except LAGB) Family or patient history of autoimmune disease

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 |
| --- | --- |
| Plicated Gastric Banding<br> | Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.<br>* PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.<br>|
| Standard Gastric Banding<br> | Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.<br>* PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Co-morbid disease resolution
Effect of Eye Make up on Ocular Surface

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the degree of tear film instability and severity of meibomian gland loss between subjects who use eyeliner, mascara, a combination of both and those who do not use eyeliner.

Official Title
-----------------
Effect of Pencil Eyeliners and Waterproof Mascara on Tear Stability Tests and Meibomography

Conditions
-----------------
Meibomian Gland Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Schirmer test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To use eyeliner/mascara or combined for at least 3 days for 6 months for study groups No routine eye make up use for the cıontrol group - Exclusion Criteria: any systemic or ocular disease taht can affect ocular surface

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal<br>no make up | Diagnostic Test: Schirmer test<br>* Tear tests Meibomian gland grading test<br>* Other names: Meibomography;|
| eyeliner only<br>three days a week at least for 6 months | Diagnostic Test: Schirmer test<br>* Tear tests Meibomian gland grading test<br>* Other names: Meibomography;|
| mascara only<br>three days a week at least for 6 months | Diagnostic Test: Schirmer test<br>* Tear tests Meibomian gland grading test<br>* Other names: Meibomography;|
| eyeliner and mascara<br>three days a week at least for 6 months | Diagnostic Test: Schirmer test<br>* Tear tests Meibomian gland grading test<br>* Other names: Meibomography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer test | Tear measurement | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non contact tear break up test | tear stability calculation | 17 seconds | 
| Meibomography | Meibomian gland loss grading | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meibomian, eyeliner
Dose Finding Study In Subjects With Crow's Feet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.

Official Title
-----------------
Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)

Conditions
-----------------
Lateral Canthal Lines, Crow's Feet

Intervention / Treatment
-----------------
* Biological: ANT-1401
* Biological: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30 - 60 years of age mild to moderate Crow's Feet wrinkles at rest moderate to severe Crow's Feet wrinkles on contraction willingness to refrain from any product affecting skin remodeling female subjects must be not pregnant and non-lactating Exclusion Criteria: history of peri-ocular surgery, brow lift or related procedures procedures affecting the lateral canthal region in the prior 12 months application of topical prescription medication to the treatment area female subjects who are pregnant or are nursing a child

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| Placebo Comparator: Vehicle<br>vehicle without ANT-1401 | Biological: Vehicle<br>* Vehicle<br>|
| Experimental: Dose 1<br>lowest dose | Biological: ANT-1401<br>* Active<br>|
| Experimental: Dose 2<br>second lowest dose | Biological: ANT-1401<br>* Active<br>|
| Experimental: Dose 3<br>mid-level dose | Biological: ANT-1401<br>* Active<br>|
| Experimental: Dose 4<br>second highest dose | Biological: ANT-1401<br>* Active<br>|
| Experimental: Dose 5<br>highest dose | Biological: ANT-1401<br>* Active<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators Global Assessment Scale | Crow's Feet Wrinkle Scale | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Self-Assessment score | Subjects self assessment of severity of Crow's Feet | up to 12 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wrinkles
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes

Study Overview
=================
Brief Summary
-----------------
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.

Official Title
-----------------
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes

Conditions
-----------------
Herpes Genitalis

Intervention / Treatment
-----------------
* Drug: ASP2151
* Drug: valacyclovir
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a history of genital HSV documented by laboratory testing at screening Subject has experienced 4 or more episodes of genital herpes during the past 12 months Exclusion Criteria: Subject is immunocompromised

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral administration of active comparator | Drug: valacyclovir<br>* Oral administration of active comparator.<br>|
| Placebo Comparator: 2<br>Oral administration of placebo | Drug: Placebo<br>* Oral administration of placebo.<br>|
| Experimental: 3<br>Dosing regimen 1 | Drug: ASP2151<br>* Oral administration.<br>|
| Experimental: 4<br>Dosing regimen 2 | Drug: ASP2151<br>* Oral administration.<br>|
| Experimental: 5<br>Dosing regimen 3 | Drug: ASP2151<br>* Oral administration.<br>|
| Experimental: 6<br>Dosing regimen 4 | Drug: ASP2151<br>* Oral administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics in study patients |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Outcome, Genital Herpes, ASP2151, Herpes Genitalis, Sexually Transmitted Disease, Herpes Simplex Virus Genital Infection
Prognostic Value of Hemodynamic Disturbances in Rhegmatogenous Retinal Detachment (CRADO-RED)

Study Overview
=================
Brief Summary
-----------------
Retinal detachments correspond to a separation of the neuroepithelium from the pigment epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional, traumatic (postoperative) or rhegmatogenous (in relation to a tear). Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile membrane. It can also measure the hemodynamic parameters of retinal arteries. A preliminary study showed a correlation between systolic velocity in the central retinal artery and postoperative visual acuity. The aim of this study is to confirm those preliminary data.

Official Title
-----------------
Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Device: color Doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years rhegmatogenous retinal detachment, relapsing or not, including pseudophakic retinal detachment or aphakic retinal detachment, if the retinal detachment occurs more than three months after phacoemulsification Exclusion Criteria: traumatic retinal detachment bilateral retinal detachment less than 3 months after phakoemulsification predictable follow-up of less than 6 months patient under of legal protection patient's opposition to participate absence of affiliation to the social security eye's axial length> 25.5 mm preoperative visual acuity greater than 70/100 no surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: retinal detachment<br>color Doppler ultrasound of the eye | Device: color Doppler ultrasound<br>* pre-operative blood flow velocity measurement with a color Doppler ultrasound device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth week of follow-up |  | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth :month of follow-up |  | Six months |