linjc16/ctgov huggingface dataset:
Zephyr Etude Post-Inscription (French Registry)

Study Overview
=================
Brief Summary
-----------------
The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

Detailed Description
-----------------
This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. Patients prescribed the Zephyr Valve treatment will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3-years post-treatment.

Official Title
-----------------
Zephyr Etude Post-Inscription (French Registry)

Conditions
-----------------
Emphysema or COPD

Intervention / Treatment
-----------------
* Device: Zephyr Valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction procedure by the physician. Subjects who signed an Informed Consent Form to allow data collection. Exclusion Criteria: Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Zephyr Valve treatment<br>Patients undergoing the Zephyr Valve treatment for emphysema/COPD | Device: Zephyr Valve<br>* Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.<br>* Other names: BLVR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 second (FEV1) | The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treated Lobar Volume Reduction (TLVR) | Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days. | 45 days |
Seizure Prophylaxis in Aneurysm Repair

Study Overview
=================
Brief Summary
-----------------
Seizures are a potential complication of surgical repair of intracranial aneurysms. In order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. Retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. The goal is to examine the utility of levetiracetam (Keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.

Official Title
-----------------
Seizure Prophylaxis in Aneurysm Repair

Conditions
-----------------
Intracranial Aneurysms, Seizures

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥18 years) Presence of intracranial aneurysm (without rupture) Treating surgeon has recommended surgical repair of the aneurysm. Exclusion Criteria: History of seizures within last 10 years History of epilepsy History of prior stroke Currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.) Brain tumor Pregnant or nursing woman Known levetiracetam allergy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levetiracetam<br> | Drug: Levetiracetam<br>* 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days<br>|
| No Intervention: No anti-epileptic treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Seizure | Reported via patient in follow-up phone call. | 6 mo - 1 Year from Operative Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Returned to Daily Activities. | The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities. | 6 months - 12 months | 
| Number of Participants Who Returned to Work | The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time. | 6 months - 12 months |
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers

Study Overview
=================
Brief Summary
-----------------
The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing. This project proposes to deepen the investigation with two main objectives: To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.

Conditions
-----------------
Periodontal Disease

Intervention / Treatment
-----------------
* Biological: periodontal pocket samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years Patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx Patients naive treatments for head and neck cancers Patients affiliated or beneficiary of a social security scheme Patients who gave informed consent in writing Exclusion Criteria: Patients treated with neoadjuvant chemotherapy, adjuvant or concomitant Patients taking immunosuppressants after organ transplantation Taking anticoagulants incompatible with dental samples (possible bleeding) Patients edentulous and / or whose dental condition is incompatible with the dental samples

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: periodontal disease<br>Saliva samples | Biological: periodontal pocket samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of level of EBV nucleic acids |  | day 1 | 
| Measure of level of EBV nucleic acids |  | day 180 |
DNA Damage and Subfertility in Males - Impact on ART Outcome

Study Overview
=================
Brief Summary
-----------------
A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).

Official Title
-----------------
DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First cycle treatment Exclusion Criteria: TESA/PESA, more than one cycle

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IUI - Insemination<br>Males of couples undergoing their first IUI treatment | |
| IVF - In vitro fertilisation<br>Males of couples undergoing their first IVF treatment. Including males of couples who have had previous IUI treatments. | |
| ICSI - Micro Insemination<br>Males of couples undergoing their first ICSI treatment. Including males of couples who have had previous IUI treatments. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of particpants achieving live birth | Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic. | week 23-42 of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinical pregnancy | Measurement of heart beat by ultrasound scan | week 7-8 of pregnancy | 
| Number of participants with biochemical pregnancy | Increase in serum hCG levels | Day 14-17 of pregnancy | 
| Cumulative live birth rate | Live births originating from one controlled stimulation. | 9-24 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male infertility, DNA fragmentation Index, DFI
Medical Expulsive Therapy Post-SWL For Renal Stones

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm

Official Title
-----------------
Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial

Conditions
-----------------
Urologic Diseases, Urolithiasis, Stone, Kidney

Intervention / Treatment
-----------------
* Drug: Tamsulosin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal stone ≤ 20 mm. Lower calyceal stone ≤ 15 mm Exclusion Criteria: Women with known or suspected pregnancy or breastfeeding. History of alpa-blockers (more than 7 days prior to study participation) History of ureteral stricture Multiple (that is more than 2) stones Stone in solitary kidney (either anatomically or functionally). Presence of urinary sepsis. Estimated glomerular filtration rate < 30 ml/min Contraindication or allergy to tamsulosin

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tamsulosin<br>tamsulosin 0.4 mg once daily | Drug: Tamsulosin<br>* Tamsulosin 0.4 mg once daily<br>|
| Placebo Comparator: Placeb<br>Placebo once daily | Drug: Placebo<br>* Placebo once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate defined as patient free of any stone residual | assessed by Non-contrast Computed Tomography of Urinary Tract (NCCT-UT) | at 3 months |
Prospective Follow-up of Patients With Chronic Inflammatory Rheumatism

Study Overview
=================
Brief Summary
-----------------
It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)

Detailed Description
-----------------
All subjects were followed up on a yearly basis collection with clinical data (weight, sex, age, comorbidities, treatment), biological (VS, CRP, ACPA, lipid balance, cross laps), radiology (hand and foot radiographs and ultrasonography ), BMO Measure

Official Title
-----------------
Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique

Conditions
-----------------
Inflammatory Disease, Rheumatoid Arthritis, Spondyloarthritis

Intervention / Treatment
-----------------
* Other: observational follow-up:clinical, radiological et biological


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years Rheumatoid arthritis meeting ACR criteria Spondyloarthritis meeting ASAS criteria Exclusion Criteria: Patient under guardianship

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 |
| --- |
|Other: observational follow-up:clinical, radiological et biological|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic maintenance at 20 years of follow-up | All subjects benefit from an annual follow-up including a collection of clinical data (age, sex, weight, comorbidities, swelling and painful joints), biological (CRP, ACPA, cross laps, lipids), radiological, BMO measures (Hologic), and treatments (biological and synthetic DMARDS). Each rheumatologic modification or stop of treatment is transcribed. Therapeutic maintenance definition: modification in rheumatologic treatment (number of DMARDS at 20 years) | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evolution of lipidics parameters at 20 years of follow-up | lipidics parameters ( total, HDL, LDL cholesterol and tryglicerides) are collected each years and modifications/evolution of these parameters will be studied | 20 years |
A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of GentleCath Glide™ Intermittent Catheters

Official Title
-----------------
A Multi-centre Clinical Investigation to Assess the Performance of GentleCath™ Glide Intermittent Catheters

Conditions
-----------------
Comfort and Performance of Intermittent Catheter

Intervention / Treatment
-----------------
* Device: Intermittent Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of 18 years old and above who require intermittent bladder drainage may be recruited into the study Subjects must be willing and able to provide written informed consent Subjects may be either inpatients or outpatients but must all be capable of completing a patient diary card to record study data Subjects must currently use intermittent catheters and have been using intermittent catheters for the last six months Patients who self-catheterise at least three times per day Able to attend final assessment visit at day 14 Exclusion Criteria Subjects who require intermittent catheterisation to administer irrigation or instillation. Subjects who are presently participating in another clinical trial. Subjects exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study Subjects with known sensitivity to the device components

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 |
| --- | --- |
| Other: Single Arm Study<br>This is a single arm study with no comparator | Device: Intermittent Catheter<br>* Intermittent urinary catheter for bladder drainage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance/Ease of Use | Performance and ease of use will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement | 14 Days | 
| Ease of Removal | Ease of removal will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement | 14 Days | 
| Residue Acceptability | Residue acceptability will be assessed by both the patient and Investigator. The data will be collected via a questionnaire. The responses will be on a 1 to 5 scale with 1 disagreeing with the statement and 5 agreeing with the statement | 14 Days |
Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in Manikin by Novice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the intubation time and success rate between videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice airway managers.

Official Title
-----------------
Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in a Normal and Cervical Immobilized Manikin by Novice

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Other: McGrath videolaryngoscopy
* Other: Pentax videolaryngoscopy
* Other: Macintosh laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nurse without experience in tracheal intubation Exclusion Criteria: refusal to consent

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McGrath videolaryngoscopy<br>Participants attempt to perform three intubation using McGrath videolaryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. | Other: McGrath videolaryngoscopy<br>* Participants perform three intubation attempts using McGrath videolaryngoscope in the normal and cervical immobilized manikin by novice<br>|
| Experimental: Pentax videolaryngoscopy<br>Participants attempt to perform three intubation using Pentax videolaryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. | Other: Pentax videolaryngoscopy<br>* Participants perform three intubation attempts using Pentax Airway Scope in the normal and cervical immobilized manikin by novice<br>|
| Active Comparator: Macintosh laryngoscopy<br>Participants attempt to perform three intubation using Macintosh laryngoscope in the manikin with the normal airway and difficult airway scenario, respectively. | Other: Macintosh laryngoscopy<br>* Participants perform three intubation attempts using Macintosh laryngoscope in the normal and cervical immobilized manikin by novice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time | time the blade passed the manikin's tooth until lung expansion with resuscitation bag | within 2 min after insertion of laryngoscope into manikin's mouth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
videolaryngoscope, novice
Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter (OTC) setting.

Official Title
-----------------
A Non-interventional, Non-controlled, Post-marketing Study to Obtain Knowledge of the Safety of ZyComb® (Xylometazoline Hydrochloride 0.5 mg/mL and Ipratropium Bromide 0.6 mg/mL) for Symptoms of Common Cold in a Real-life OTC Setting

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For inclusion the patient must buy ZyComb® nasal spray with the intention to start using it either the same or the next day.

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

| Intervention/Treatment |
| --- |
|Drug: xylometazoline hydrochloride and ipratropium bromide (ZyComb)|Common cold in a real-life OTC setting|

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

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