linjc16/ctgov huggingface dataset:
Multiperfusion Neonatal System

Study Overview
=================
Brief Summary
-----------------
Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter. In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs. Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.

Official Title
-----------------
Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Device: Multiline Neo®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born between November 30, 2018 and December 31, 2022, Gestational age below 33 weeks Exclusion Criteria: Severe malformation and / or disease requiring heavy surgical management in the neonatal period Admitted at croix rousse hospital after the third day of life
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Very preterm infants born between November 30, 2018 and November 30, 2019<br>Infants born between November 30, 2018 - November 30, 2019, before implementation of the new multiperfusion neonatal system | |
| Very preterm infants born between December 1st, 2019 and December 31st, 2022<br>Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system | Device: Multiline Neo®<br>* Multiperfusion neonatal system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of infection | Number of infections per 1000 catheter days, per patient during hospital stay | through study completion, an average of 60 days |
Ultrasound Assessment During Exercise

Study Overview
=================
Brief Summary
-----------------
This study evaluates the ability of the transverse abdominis (TrA) to contract during and after two different types of exercise - either sling based exercise or traditional core stability exercise. The TrA is measured by real time ultrasound imaging. The investigators hypothesized that the sling based exercise would activate the TrA to a greater degree and that there would be a greater activation after the exercise.

Official Title
-----------------
Assessment of Transverse Abdominis Muscle Function Associated With Stabilization Exercises in Low Back Pain Patients

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Core stability exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain with stabilization classification Exclusion Criteria: Fractures, neurological condition

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Exercise<br>* Redcord (sling exercise) and traditional exercise<br>|
| Active Comparator: Core stability exercise<br>Traditional core stability exercise | Other: Core stability exercise<br>* Traditional core stability exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TrA activation ratio measured by RUSI |  | Pre - during - post exercise during a single day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Core, Redcord, RUSI, low back
Study of Effectiveness of Mexyn-A

Study Overview
=================
Brief Summary
-----------------
Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal, non-flammable, pressurised spray which embodies in one simultaneous application, most of the currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies and hydrotherapy.

Detailed Description
-----------------
The primary clinical endpoint was to establish MEXYN-A efficacy and safety in abolishing or reducing pruritus related to cutaneous diseases, insect bites and poison ivy, within few seconds of the application. The secondary endpoint was to measure the itch free period as a result of the new intervention.

Official Title
-----------------
Proof of Concept of MEXYN-A

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Device: Mexyn-A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from severe itching due to : Atopic Dermatitis, contact dermatitis, psoriasis, urticaria, xerosis, prickly heat, genital pruritus, chicken pox, aquagenic pruritus, lichen planus, poison ivey, insect bites. Past experience with the use of at least one conventional medication for pruritus or conventional medication for the same disorder patients suffered. Exclusion Criteria: Patients who have taken any anti-pruritic drug during the month prior to participation. Patients who have taken drugs for any reason for 2 days prior to participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 Years

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

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

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: 1<br>Mexyn-A | Device: Mexyn-A<br>* Atomised topical self-chilled pressurised spray<br>* Other names: Clearitch, Itcharret, itchclear, Magicool-Plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treating Pruritus |  | three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring itch-free period after applying the new treatment, effect on sleep disturbance |  | three days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pruritus, itching, mexyn-a, clearitch, magicool-plus
Oslo Balloon Angioplasty Versus Conservative Treatment

Study Overview
=================
Brief Summary
-----------------
Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data. The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA. Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers

Official Title
-----------------
Oslo Balloon Angioplasty Versus Conservative Treatment

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Procedure: lifestyle, PTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age below 75 years Symptoms of intermittent claudication with duration > 3 months ABPI <0.9 A two-year follow-up is possible Exclusion Criteria: Subjective pain-free walking distance > 400m Critical ischemia Previous vascular or endovascular surgery Diabetes ulcer Other physical disability abrogating organised exercise Use of warfarin Mentally unable to give informed consent Renal insufficiency Coagulation disorders Duplex or PTA impossible

Ages Eligible for Study
-----------------
Maximum Age: 75 Days

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

| Intervention/Treatment |
| --- |
|Procedure: lifestyle, PTA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient quality of life. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, quality of life, pain-score, biomarkers
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

Official Title
-----------------
A Prospective Phase IV, Multicentre, Placebo-controlled Study to Demonstrate Changes in the Quality of Life Following DYSPORT Intramuscular Injection in the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients

Conditions
-----------------
Cerebrovascular Accident, Muscle Spasticity

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously. The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale. The patient has the cognitive and communication ability to participate in the study. Exclusion Criteria: Patients who have received botulinum toxin treatment within the past 120 days. Contraindication to botulinum toxin treatment. Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry. Patients who have previously been treated with phenol for their upper limb spasticity.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysport<br> | Biological: Botulinum toxin type A<br> <br> * Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle spasticity assessed on Modified Ashworth Scale (MAS) |  |  | 
| Change in the Modified Motor Assessment Scale |  |  | 
| Change in patient disability and carer burden rating scale total score |  |  | 
| Achievement of the patient identified functional outcome measures (Goal Attainment Scaling) |  |  | 
| Change in the degree of pain |  |  | 
| Change in depression rating scale total score |  |  | 
| Global assessment of benefit |  |  |
Auto-inoculation of a Wart in Multiple Viral Warts

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to see effectiveness of auto-inoculation of a wart in multiple viral warts. Patients with recurrent, multiple warts of all types, are being recruited for the study. A wart is excised, minced and then inoculated in a subcutaneous pocket made on the volar aspect of forearm. Patients are to be reviewed after every 4 weeks to note any reduction in number warts.

Detailed Description
-----------------
A single arm, Phase 1, Clinical Study

Official Title
-----------------
Effectiveness of Auto-inoculation of a Wart in Multiple Viral Warts, in Tertiary Care Hospital : A Single Arm Study

Conditions
-----------------
Viral Wart, Delayed Hypersensitivity

Intervention / Treatment
-----------------
* Procedure: Auto-inoculation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals having 5 or warts Individuals having any types of warts Exclusion Criteria: Individuals using any other treatment for warts
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Auto-inoculation recipients<br>Auto-inoculation of wart to be performed | Procedure: Auto-inoculation<br>* A wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance of Warts | All the warts on any part of the body are cleared | 12 weeks | 
| Incomlete Clearance of Warts | No or size of warts are reduced | 12 weeks | 
| Non Responders | If no change or increased no of warts | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autoinoculation, Viral Warts, Hypersensitivity, Immunology
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.

Detailed Description
-----------------
This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.

Official Title
-----------------
Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer

Conditions
-----------------
Previously Treated Metastatic Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo. Measurable disease Good performance status (ECOG 0,1 or 2) Exclusion Criteria: Previously treated with Oxaliplatin or Navelbine Symptomatic CNS metastases

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Duration of response |  |  | 
| Survival |  |  | 
| Toxicity profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer
The Early Diagnosis of Gestational Diabetes Mellitus Study

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an early diagnosis method of GDM in low risk pregnant women. By investigating maternal and neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.

Conditions
-----------------
Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: glycemic monitoring
* Dietary Supplement: dietary guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnant women will be invited to participate in this study if they are between 18 and 40 years of age, and have had their first prenatal visit in our center before 18 weeks 0 days of gestation. Exclusion Criteria: Previous history of GDM or preexisting DM Family history of diabetes mellitus (first degree relative with diabetes or a sister with GDM) Body mass index>30 kg/m2 Previous macrosomia (baby with birth weight >4,000 g) or a history of stillbirth Polycystic ovary syndrome Medications: corticosteroids, antipsychotics Participant not willing to take OGTT twice (at 18-20 gestational weeks and 24-28 gestational weeks), or not willing to have a series of prenatal care visits and deliver in our center.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>As a diagnostic study, the cohort will recruit 300 pregnant women who meet inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early-OGTT) and 24 to 28 gestational weeks (regular-OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis. | Behavioral: glycemic monitoring<br> <br> Dietary Supplement: dietary guide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of GDM diagnosed in 18-20 gestational week. |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational Diabetes Mellitus, Oral Glucose Tolerance Test