linjc16/ctgov huggingface dataset:
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Study Overview
=================
Brief Summary
-----------------
The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa. Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization. The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.

Detailed Description
-----------------
It consists of a study of a prospective cohort in 36 centers, for 3 years, from April 1st 2008. The data of all patients who received rFVIIa in traumatic situation were collected. The investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rFVIIa, length of stay in ICU, secondary effects, complications and patients outcome. ISS and TRISS score were calculated to predict mortality.

Official Title
-----------------
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Conditions
-----------------
Hemorrhage, Bleeding

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people affiliated to social security patients admitted in ISU for haemorrhagic trauma patients received rFVIIa after the other treatment for bleeding control Exclusion Criteria: allergy or hypersensitivity to rVIIa or one of its component

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 |
| --- | --- |
| observational study<br>haemorrhagic trauma received rFVIIa | Other: observational study<br>* data collected by investigators<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of rFVIIa in haemorrhagic trauma compared to guidelines | Deviations with European guidelines use of rFVIIa | twenty four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medico economic evaluation | number of patients receiving rFVIIa by year and posology by patient | one year | 
| security and efficiency use of rFVVa | Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence | thirty days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRAUMA, HAEMORRHAGIC, rVIIa, Complication of Trauma hemorrhage, bleeding, rFVIIa administration for hemorrhage after trauma
A Retrospective, Observational Registry of Participants With Avian Influenza Infection

Study Overview
=================
Brief Summary
-----------------
This is a global, multi-center, observational registry of participants with suspected or confirmed infection with avian influenza A H5N1. Data are collected through retrospective abstraction, from detailed case reports that may be published and available in the public domain, or as incident cases received directly from the treating physician or other medical personnel.

Official Title
-----------------
Avian/Pandemic Influenza Registry

Conditions
-----------------
Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who develop influenza-like symptoms and who are considered to be epidemiologically linked by time, place, and exposure to a probable or confirmed avian influenza or human case of H5N1 infection are eligible for inclusion in the Registry. Cases with atypical symptom presentation (e.g., non-respiratory) are also included, in keeping with evolving knowledge about the clinical presentation of avian influenza. Participants with documented positive serological test who either remain asymptomatic or experience mild illness only Participants with laboratory confirmation of infection with influenza A (H5N1) who survive long enough to present for medical care Exclusion Criteria: - There are no exclusion criteria in this study

Ages Eligible for Study
-----------------
Maximum Age: 120 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 |
| --- | --- |
| Avian influenza A<br>Natural history of Avian influenza A, particularly H5N1 strain which has a high potential of causing a global human pandemic, and real-world treatment practices will be observed in this study. This registry program will not require, recommend, or provide any specific treatment or medications. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with clinical outcome (death, recovery, or other overall clinical status) at the time of discharge from care |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with at least One Adverse Event (AE) |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avian Influenza
Lifestyle Intervention in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The long term effects of organized lifestyle intervention on weight loss, physical fitness and quality of life in morbidly obese patients have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle intervention in a primary care setting with respect to long term (4-years) changes in weight loss, physical fitness and quality of life

Detailed Description
-----------------
Due to limited recruitment from GP, the study design has been changed into an observational long term study following the participants in the intensive lifestyle intervention group

Official Title
-----------------
Lifestyle Intervention in Morbidly Obese Patients

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbidly obese patients not planned for bariatric surgery Exclusion Criteria: Participation in other weight loss programs during the last 12 mths Serious psychiatric conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ILI-group<br>Intensive lifestyle intervention at a tertiary care rehabilitation center. Treatment included changes in both dietary habits (calori restriction) and physical activity with particularly high intensity the first 3 months. | Behavioral: Lifestyle intervention<br>* Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study<br>|
| Active Comparator: MLI<br>Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity. | Behavioral: Lifestyle intervention<br>* Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss, physical fitness and quality of life |  | 1 and 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Physical fitness, Quality of life
Family & Friends - the Significance of a Significant Other in Treatment

Study Overview
=================
Brief Summary
-----------------
This study focuses on the difficulties to maintain a weight loss and behavioural change after having been in a institutional intermittent weight loss programme. We explore if including a member of the family or a close friend in the treatment influences weight loss maintenance after completion of the programme.

Official Title
-----------------
Conservative Treatment of Obesity at Røros Rehabilitation Centre - A Randomised Trial

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: With friend
* Behavioral: Without friend


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obesity 18-50 years of age Having a relative or close friend who is willing to participate Exclusion Criteria: Pregnancy Serious mental illness Severe overeating behaviour Significant reduced physical functioning Having undergone bariatric surgery earlier Serious heart disease

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Without friend<br>Being in the weight loss programme without friend or family member | Behavioral: Without friend<br> <br> |
| Experimental: With friend<br>Having the friend or family member stay together with the patient for 2-3 days for every 3 week stay at the clinic in the weight loss programme | Behavioral: With friend<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of weight loss |  | 2 years after termination of programme | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss, Social support
Sleep Well for Healthy Brain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.

Official Title
-----------------
Lifestyle Stressors of Hippocampus and Alzheimer's Disease (AD) Related Brain Regions: Potential for Intervention

Conditions
-----------------
Poor Quality Sleep

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment. Exclusion Criteria: pregnant women cognitively impaired subjects not able to provide consent prisoners Subjects 55 years of age and older that meet criteria for mild cognitive impairment. Subjects with any neurological disorder. Any other condition that in the opinion of the investigator may affect the participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy (CBT) Group<br>Participants will receive CBT intervention bi-weekly for total of six (6) sessions. | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line.<br>|
| No Intervention: Control Group<br>Participants will not receive any intervention as part of the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of brain tissue volume loss in specific brain regions | As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan | Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Performance | Cognitive performance will be assessed using a Memory test which has a composite score ranging from 80 to 120 % with a higher score indicating better performance and a midrange at 100%. | Year 2 |
Safety of Preoperative Oral Administration of a High Caloric Drink With Protein

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia.

Official Title
-----------------
Safety of Preoperative Oral Administration of a High Caloric Drink With Protein in Patients With Dysgnathia

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: high caloric drink with protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with surgery for dysgnathia Exclusion Criteria: Diabetes mellitus

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: high caloric drink with protein|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric residual at induction of anesthesia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative wellness |  |  | 
| thermoregulation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preoperative nutrition, postoperative nausea and vomiting, Dysgnathia, anesthesia
Phacotrabeculotomy Versus CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.

Official Title
-----------------
Phacotrabeculotomy vs. CCI+Phaco in Patients With Borderline Control of Intraocular Pressure

Conditions
-----------------
Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma

Intervention / Treatment
-----------------
* Procedure: Phacoemulsification, implantation of intraocular lens
* Procedure: Phacoemulsification, Implantation of IOL, trabeculotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of Primary Open Angle or Pseudoexfoliative Glaucoma and Cataract Exclusion Criteria: Other glaucoma than POAG or PEX-Glaucoma Medically uncontrolled Glaucoma: IOP > 24 mmHg with two topical medications IOP > 21 mmHg with three topical medications IOP < 18 mmHg with two topical medications IOP < 16 mmHg with three topical medications previous ocular surgery other ocular pathologies affecting visual acuity disorders of immune system

Ages Eligible for Study
-----------------
Minimum Age: 50 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Phacoemulsification, implantation of intraocular lens|nan|
|Procedure: Phacoemulsification, Implantation of IOL, trabeculotomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Constant Intraocular Pressure <18 mmHg with/without medication |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Constant Intraocular Pressure <18 mmHg without medication |  |  | 
| Number of Patients with Constant Intraocular Pressure <21 mmHg with/without medication |  |  | 
| Number of Patients needing surgical retreatment |  |  | 
| Number of Patients with failure of surgical retreatment |  |  | 
| Mean IOP after 1 and 2 years |  |  | 
| Mean number of medication after 1 and 2 years |  |  | 
| Number of intraoperative complications |  |  | 
| comparison of postoperative complications between the groups |  |  | 
| Visual acuity |  |  | 
| decrease in perimetry |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, cataract, surgery, intraocular pressure, phacoemulsification, trabeculotomy
Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.

Official Title
-----------------
Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

Conditions
-----------------
Cataract, Astigmatism

Intervention / Treatment
-----------------
* Device: Tecnis implant
* Device: ReSTOR implant
* Device: ReZoom implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D Exclusion Criteria: Any ocular diseases, such as: corneal opacities or irregularity dry eye amblyopia anisometropia glaucoma retinal abnormality Surgical complications IOL tilt IOL decentration greater than 0.4 mm (estimated by retroillumination) Incomplete follow-up

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tecnis<br> | Device: Tecnis implant<br>* Implant of diffractive multifocal IOL Tecnis<br>|
| Active Comparator: ReSTOR<br> | Device: ReSTOR implant<br>* Implant of multifocal IOL ReSTOR<br>|
| Active Comparator: ReZoom<br> | Device: ReZoom implant<br>* Implant of multifocal IOL ReZoom<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity, wavefront data and modulation transfer function |  | 30, 90 and 120 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast sensitivity |  | 90 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wavefront, multifocal IOL, modulation transfer function, intraocular lenses, wavefront data, Visual performance
Clinical Study on the Safety of SAFIL® MESH

Study Overview
=================
Brief Summary
-----------------
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects

Detailed Description
-----------------
The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020

Official Title
-----------------
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects

Conditions
-----------------
Abdominal Wall Defect, Ventral Hernia, Abdominal Hernia, Fascial Hernia

Intervention / Treatment
-----------------
* Device: Hernioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh Exclusion Criteria: No exclusion criteria have been set.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Safil Mesh<br> | Device: Hernioplasty<br>* Hernioplasty is the repair of the defect using mesh patches.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia rate | Rate of hernias occuring during follow-up of retrospectively included patients | at one follow-up 12-30 months after initial intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative complications | Retrospective documentation of Number of Participants with intraoperative Complications | intraoperatively | 
| Post-operative complications | Number of retrospectively included participants having complications during follow-up of | at one follow-up 12-30 months after initial intervention | 
| Reintervention rate | Complications leading to reintervention during follow-up of retrospectively included patients | at one follow-up 12-30 months after initial intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reinforcement of Soft Tissues, Hernioplasty, mesh repair