linjc16/ctgov huggingface dataset:
High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

Study Overview
=================
Brief Summary
-----------------
Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern. The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

Detailed Description
-----------------
Aims: To establish a safe, efficient routine for implementation of HS in daily treatment and to investigate the efficiency and tolerance of high volumes of HS integrated with chest physiotherapy. HS was given twice daily with volumes of 4,5 ml in children aged 0-5 years, 6 ml at age 6-16 years and 9 ml at age > 16 years. The protocol included guidance of standardized breathing pattern, upright and sideways positioning and voluntary cough.

Official Title
-----------------
Establishment and Implementation of Nebulised High Volumes of Hypertonic Saline in Cystic Fibrosis Patients

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Device: Hypertonic saline
* Procedure: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cystic fibrosis Exclusion Criteria: Non-adherence
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: Physiotherapy and hypertonic saline<br>Chest physiotherapy integrated with inhalation of hypertonic saline | Device: Hypertonic saline<br>* 1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily<br>Procedure: Physiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance and safety of high volumes of inhaled hypertonic saline measured by forced expiratory volume at one second |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation of nebulised high volumes of hypertonic saline in cystic fibrosis patients | Establishment of a standardized routine of nebulised high volumes of hypertonic saline including chest physiotherapy in cystic fibrosis patients | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertonic saline, Lung physiotherapy
Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning most often in subjects aged 20-40 years. In France, thanks to recent studies reported during general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3 / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy, the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year. The primary objective of this pilot study is to assess the levels of glutamate and aspartate (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in 40 patients experiencing an event demyelinating central nervous system.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Biological: glutamate and aspartate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman between 18 and 60 years old. Patient with one or more type of inflammatory events of Central system suggestive of demyelinating disease (multiple sclerosis, neuromyelitis optical Devic extensive myelitis) No treatment with corticosteroids for less than 1 month Need for a lumbar puncture performed in the etiologic Need a brain MRI performed within the etiologic Patient who signed informed consent Exclusion Criteria: Secondary progressive MS Any cons-indication for lumbar puncture Any contra-indication to MRI Minor patient or patient major under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>Healthy Volunteers | Biological: glutamate and aspartate<br> <br> |
| Other: Multiple Sclerosis patient<br>Multiple Sclerosis patient | Biological: glutamate and aspartate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glutamate concentration (in nM) | comparison between MS patients and controls | baseline |
Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).

Detailed Description
-----------------
Prospective interventional clinical trial Single center, outcome assessor-masked, active control, randomized controlled trial

Official Title
-----------------
The Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome: A Randomized Controlled Trial

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: Mitomycin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma with primary mmc-trabeculectomy indication Exclusion Criteria: combined phacoemulsification with trabeculectomy no more than 6 month of cataract surgery before trabeculectomy revised trabeculectomy active uveitic glaucoma neovascular glaucoma par planar vitrectomy conjunctival surgery allergy to bevacizumab or mitomycin C ischemic heart disease cerebrovascular disease renal failure liver failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mitomycin c<br>Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application | Drug: Mitomycin C<br>* Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application<br>* Other names: MMC;|
| Experimental: Bevacizumab<br>Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application | Drug: Bevacizumab<br>* Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleb characteristic grading |  | 6 month | 
| systemic Blood pressure |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trabeculectomy, bevacizumab, intraocular pressure
Magnetoencephalography (MEG), Attention and Conscience

Study Overview
=================
Brief Summary
-----------------
The tight relationship between attention and conscious perception makes them difficult to study in isolation and has led many scientists to closely link these two processes. However, while some authors argue that conscious perception cannot occurs without attention, magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are two distinct brain processes. If endogenously triggered attention and consciousness are dissociated, it has been proposed that orienting of exogenous attention is a necessary, though not sufficient, antecedent of conscious perception. In the present study we used MEG to explore the neural correlates of exogenous attention and consciousness during visual processing.

Official Title
-----------------
Spatio-temporal Dynamic of the Relationship Between Spatial Attention and Visual Awareness

Conditions
-----------------
Change in Sustained Attention, Awareness, Reaction Time

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged between 18 and 40 who have signed informed consent for participation to the study and are affiliated to a social security regimen right-handler, without auditory or visual deficit Exclusion Criteria: history of neurological or psychiatic disease medication sensory disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity during visuo-spatial attention tasks | Magnetoencephalography will be used to measured cerebral evoked potential and oscillatory activity, while subjects will performed a visuo-spatial attention task. | Three years |
The Effective Ways of Recruiting Lapsed Blood Donors: a Stratified Randomized Pilot Study

Study Overview
=================
Brief Summary
-----------------
Blood donor recruitment is an important issue in every country, since the blood supply pressure become more and more intense. Donor retention is even more important, because it is easier to recruit an old customers than a new one. Therefore, figuring the most effective ways of recruiting lapsed blood donors and understanding the reasons of not donating blood again is critical and vital for the development of blood donation.

Conditions
-----------------
Blood Donor

Intervention / Treatment
-----------------
* Other: Text message
* Other: Telephone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donated blood at least once between 2009 to 2013, and the blood test result is qualified. Exclusion Criteria: Having donated again before intervened.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text group<br>Text messages containing reminds of blood donation information would be sent to donors in this group. | Other: Text message<br>* Text messages would be sent via the messaging platform of Guangzhou Blood Center. The feedback of sending status (received, failed to receive, or unknown) would be marked on every number. Four to six months follow-up, blood donation rate would be checked.<br>|
| Experimental: Telephone group<br>Investigators would give telephone calls to the donors in this group, ask the reasons why they stopped donating blood. | Other: Telephone<br>* Status (response, no answer, line issue, wrong number or refused to be interviewed) of every donor in this groups would be marked. Four to six months follow-up, blood donation rate would be checked.<br>|
| No Intervention: Control group<br>No intervention will be giving to this group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood donation rate | Number of blood donors donate blood again divided by the number of participants in every group after intervened. | four to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons of not donating again | The reasons of not donating again in the telephone group. | 1 months |
First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100

Study Overview
=================
Brief Summary
-----------------
A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers.

Official Title
-----------------
Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: CM3.1-AC100
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated informed consent prior to any study specific procedures Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive) Judged as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) Exclusion Criteria: Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator Blood donation within 3 month before administration of the IP Have a history of hypersensitivity to the IP or any of the excipients or to medicinal products with similar chemical structures

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM3.1-AC100<br> | Drug: CM3.1-AC100<br>* Solution for sc injection, single ascending doses<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution for sc injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire) |  | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First time in man, safety study, Cm3.1-AC100, Male volunteer aged 18 to 50 years at Screening
5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results

Study Overview
=================
Brief Summary
-----------------
The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. Data will be collected through review of medical records from clinical visits with physician. The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.

Official Title
-----------------
An Ongoing, 5-year Post Market Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile (GEP) Assay Results and the Impact on Patient Outcomes and Health Economics

Conditions
-----------------
Cutaneous Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data. 16 Years and older Exclusion Criteria: Less than 16 Years of age

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted surveillance regimen | Relaxed surveillance for the low risk group; Increased vigilance for early detection in the high risk group. | upon receipt DecisionDX-Melanoma results received and every 6 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. | referral to SLNB in HR melanoma | Upon receipt DecisionDx-Melanoma results | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, cutaneous melanoma, DecisionDx-Melanoma
A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis

Study Overview
=================
Brief Summary
-----------------
Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.

Detailed Description
-----------------
This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.

Official Title
-----------------
Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis

Conditions
-----------------
Chronic Bronchitis

Intervention / Treatment
-----------------
* Drug: Faropenem medoxomil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation Exclusion Criteria: Gold criteria III

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>faropenem medoxomil | Drug: Faropenem medoxomil<br>* 600 mg BID for 5 days<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo tablets BID for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Clinical response at test of cure. |  | Day 8 to 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchitis, AECB