linjc16/ctgov huggingface dataset:
Assessment of the Endovascular Aortic Aneurysm Repair's (EVAR) Main Body Lateral Movement Impact on the Rate of Reintervention After AAA's Treatment

Study Overview
=================
Brief Summary
-----------------
The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.

Official Title
-----------------
Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female > 18 years old All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic) Exclusion Criteria: Patient in emergency situation (ruptured abdominal aortic aneurysm) Life expectancy supposed to be inferior to 1 year Legal incapacity or limited capacity Pregnant female Patient unlikely to cooperate with the study Patient without health insurance

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Reintervention rate | For the the reintervention rate, all the intervention relative to a failure of the EVAR will be taken in account: as - Endoleak - Thrombosis - Conversion to open surgery - Infection - Secondary rupture | through study completion, an average of 5 years | 
| Lateral movement of the EVAR | The lateral movement is defined by a movement of more than 5 mm. | through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVAR's movements: other than lateral. | Other than lateral | 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years. | 
| Moving | EVAR's movement in relation to distal or proximal anchorage zones | 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years. | 
| Compliance | The number of CT scanner compared to the number recommended by the Haute Autorité de Santé (HAS) | 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic, endovascular, aneurysm
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.

Study Overview
=================
Brief Summary
-----------------
This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.

Official Title
-----------------
A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis.

Conditions
-----------------
Crohn's Disease, Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: Probiotic - VSL#3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 16 years of age or older Diagnosis of Crohn's disease Resection of ileocolonic Crohn's disease and small bowel to colonic anastomosis within 30 days of randomization Able to provide informed written consent Women of child-bearing potential with a negative serum pregnancy test, and/or use of effective contraception Exclusion Criteria: Use of perioperative steroids in tapering doses and anti-diarrheal agents Treatment with a TNF-antagonist in the 8 weeks prior to resection Clinically significant Crohn's disease elsewhere in the GI tract Clinically documented short bowel syndrome Serious disease other than Crohn's disease Impaired liver or renal function History of cancer with less than 2 years disease-free state Abnormal Laboratory values Alcohol or drug abuse Some psychiatric conditions Patients using other study medications Patients who are unable to attend study visits or comply with study procedures Positive pregnancy test

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Probiotic - VSL#3|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of severe endoscopic recurrence of Crohn's disease. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic recurrence at 90 days and 360 days |  |  | 
| Crohn's Disease Activity Index (CDAI) |  |  | 
| Quality of life |  |  | 
| Safety and tolerance of VSL#3 |  |  |
Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia

Study Overview
=================
Brief Summary
-----------------
Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. The purpose of this study is to provide data about multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects also data of non-affected relatives is collected (second cohort). the questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request.

Detailed Description
-----------------
Specific aspects include potential consequences from iron deficiency, efficacy and safety of self-packing, effect of female sex hormones, mortality, effects on the immune system.

Official Title
-----------------
A Questionnaire Based Study on Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia (HHT)

Conditions
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT)

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of Hereditary Haemorrhagic Telangiectasia Exclusion Criteria: unable to provide informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with HHT<br>patients with Hereditary Haemorrhagic Telangiectasia | Other: questionnaire<br>* a questionnaire based study<br>|
| control cohort<br>indirectly only as a control cohort in questionnaire of affected persons | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of nasal self-packing to treat epistaxis on the quality of life in patients with HHT measured mainly by Glasgow Benefit Inventory (GBI) | Hereditary Haemorrhagic Telangiectasia is characterised by recurrent epistaxis which can lead to a feeling to lose control. The investigators examine whether the use of high volume low pressure nasal packing is a secure and practical method to improve patients' quality of life. | 34 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 34 months |
Double Blind Atorvastatin Amlodipine Study

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia. Amlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied.

Official Title
-----------------
Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.

Conditions
-----------------
Angina

Intervention / Treatment
-----------------
* Drug: amlodipine
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours. Total cholesterol > 5.2 mmol/L (200 mg/dL) on diet alone. Exclusion Criteria: Myocardial infarction within 2 months prior to the study. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amlodipine|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and |  |  | 
| week 26. Inflammatory markers to be analyzed are the following: C-reactive |  |  | 
| protein, amyloid A and interleukin 6. |  |  | 
| From the exercise tolerance tests the time to onset of 1 mm ST depression, time to |  |  | 
| onset of angina and total exercise time will be assessed at baseline (week 2), |  |  | 
| week 18 and week 26. |  |  |
Creation and Setting up of Therapeutic Programs, Interprofessional Communication, Patients' Education and Counseling

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to suggest system for improving patients' management through a detail analysis of physical therapy departments functioning

Detailed Description
-----------------
First phase: Description of the actual patients' management through individual semi directive interviews and focus groups of health professionals, patients, and members of the hospital directory departments. Identification of barriers Second phase: suggestion of system for improving patients' management

Official Title
-----------------
Creation and Setting up of Therapeutic Programs, Interprofessional Communication, Patients' Education and Counseling: a Qualitative Study in 3 Physical Therapy and Rehabilitation Departments

Conditions
-----------------
Professionals and Patients in the Department of Physical Medicine and Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For doctors: affiliation to physical therapy and rehabilitation departments, age, career and function For other health professionals: affiliation to physical therapy and rehabilitation departments, service length, age, gender For patients: age, gender and therapeutic programs Exclusion Criteria: - Persons not wishing to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Patient management system | Qualitative study in the form of semi-structured individual interviews and group meetings (focus group) with health professionals, patients (and members of the hospital management to collect comprehensive information, prior to the formalization and implementation of specific actions. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
qualitative study, rehabilitation, physical therapy, patient education, health care, administration, patient satisfaction, handicap
Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology

Study Overview
=================
Brief Summary
-----------------
Bronchospasm during anaesthesia is a rare but potentially life-threatening event. They are classically part of IgE-dependent anaphylaxis but can also occur as an independent clinical entity, triggered by inflammatory factors such as smoking, chronic bronchitis, asthma, overweight and mechanical factors such as tracheal intubation. The etiological diagnosis is currently established during an allergy-anaesthesia consultation after skin testing for drugs used for induction of anaesthesia and antibiotic therapy when it is attributable. The aim of this study was to determine the characteristics that differ between 2 groups: isolated non-allergic bronchospasm and bronchospasm as part of an immediate allergic hypersensitivity reaction.

Official Title
-----------------
Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology

Conditions
-----------------
Bronchospasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to the allergy consultation for investigation of an immediate hypersensitivity reaction, involving a bronchospasm explicitly identified by the anaesthetist, which occurred during an anaesthetic procedure. Exclusion Criteria: None
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 |
| --- | --- | --- |
| Clinical reactions | To show that clinical reactions presented by patients with non-allergic bronchospasm are different from those presented with allergic bronchospasm (Presence or absence of associated signs such as hypotension, heart rate variation, skin signs, desaturation, EtCO2 variation). | Baseline (J0) | 
| Treatments provided | To determine whether the treatments provided to patients with non-allergic bronchospasm are different from those provided to patients with allergic bronchospasm. | Baseline (J0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial spasm, general anaesthesia, allergy, anaphylaxis
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

Study Overview
=================
Brief Summary
-----------------
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)

Detailed Description
-----------------
The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).

Official Title
-----------------
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: MADIT-CRT ICD
* Device: MADIT-CRT CRT-D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States Exclusion Criteria: Patients who are unable or unwilling to comply with the protocol requirements

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| MADIT-CRT ICD<br> | Device: MADIT-CRT ICD<br>* Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.<br>* Other names: Market approved Boston Scientific implantable cardioverter defibrillators;|
| MADIT-CRT CRT-D<br> | Device: MADIT-CRT CRT-D<br>* Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.<br>* Other names: Boston Scientific market approved cardiac resynchronization therapy defibrillators;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | Outcome measured for total population. Not broken down by indication received. | 5 years |
Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

Study Overview
=================
Brief Summary
-----------------
This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and treatment compliance in those with a history of mild to moderate TBI and persistent cognitive complaints.

Official Title
-----------------
Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

Conditions
-----------------
PTSD With a History of Mild to Moderate TBI

Intervention / Treatment
-----------------
* Behavioral: CPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) OEF/OIF veteran; 2) Current diagnosis of PTSD; 3) History of mild-to-moderate TBI; 4) Subjective cognitive complaints; 5) No anticipated/pending medication changes; 6) Written informed consent to participate in the study. - Exclusion Criteria:1) Active substance dependence, 2) Suicidal intent or attempt within the previous month; 3) Current psychotic disorder; 4) Dementia; 5) Non-English speaking; 6) Participation in other intervention studies. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: SMART-CPT<br>CPT with additional elements of cognitive rehabilitation | Behavioral: CPT<br> <br> |
| Active Comparator: CPT<br>Standard Cognitive Processing Therapy | Behavioral: CPT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist |  | change from baseline PTSD Checklist at 12 weeks (post-treatment) |
Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.

Official Title
-----------------
Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AKI stage 3 At least 18 years old Exclusion Criteria: ESRD patients (eGFR < 15 mL/min/1.73 m2)

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 |
| --- | --- |
| AKI patients stage 3<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year mortality |  | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  | 28-day | 
| RRT rate |  | 28-day | 
| Renal recovery | Number of Participants with who survive. Number of Participants with dialysis independence and creatinine <1.5 mg/dL | 28-day | 
| 2-year major adverse kidney events | Number of Participants with 25% or greater decline in eGFR. Number of participants who receive new renal replacement therapy (RRT). | 2-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute kidney injury, Renal replacement therapy, Intensive Care Unit