linjc16/ctgov huggingface dataset:
PRESERVE-Zenith® Iliac Branch System Clinical Extended Study

Study Overview
=================
Brief Summary
-----------------
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms

Official Title
-----------------
Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation With the ConnectSX™

Conditions
-----------------
Aorto-iliac Aneurysms, Iliac Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An aortioiliac or iliac aneurysm An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Unsuitable arterial anatomy

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 |
| --- |
|Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation System|Zenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zenith aortoiliac aneurysm, iliac aneurysm, branch, connections, endovascular graft, graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Emergency general surgical care during the COVID-19 pandemic presents a unique set of considerations and challenges. Patients presenting with acute surgical conditions and concomitant COVID-19 infection have higher risk of mortality and morbidity. The investigators present their experience with COVID-19 positive patients presenting with acute surgical conditions and reviewed the implementation of a protocolized pathway to mitigate the impact of COVID-19 infection.

Detailed Description
-----------------
All COVID-19 positive patients who presented to the acute general surgical service over a 2-month period were identified. Patient data including demographics, surgical diagnosis, mortality, morbidity and hospital length of stay was collected. Based on the investigators' early experience from the first patient, the investigators designed a protocolized institutional pathway which incorporated the risk of COVID-19 infection and urgency of operation.

Official Title
-----------------
Delivery of Protocolised Emergency Surgical Care During COVID-19 Pandemic Based on Case Series

Conditions
-----------------
COVID-19, Emergency Surgery

Intervention / Treatment
-----------------
* Procedure: Emergency surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with emergency surgical conditions and tested positive for COVID-19 infection Exclusion Criteria: Nil

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 |
| --- |
|Procedure: Emergency surgery|Emergency surgery vs conservative management|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical morbidity in patients with COVID-19 infection and general surgical conditions |  | Follow up 1 month |
Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.

Official Title
-----------------
A Prospective, Single Site, Single-arm Study Designed to Evaluate the Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation

Conditions
-----------------
Physical Rehabilitation

Intervention / Treatment
-----------------
* Device: BioGaming YuGo System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is willing to comply with protocol-specified evaluations Subject signed informed consent Exclusion Criteria: Pregnant or nursing female subjects Surgical procedures or injuries to the extremities that could potentially affect physical functions Neurological and/or vestibular disease Cognitive impairment Subjects taking any prescribed drugs that could potentially affect physical function and balance

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioGaming YuGo System<br> | Device: BioGaming YuGo System<br>* Subjects will perform a customized training program predefined in the BioGaming YuGo system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements. | Activity movements are assessed by independent clinicians. | Baseline procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Record of any adverse event | Any adverse event occurring during the baseline procedure will be recorded. | Baseline procedure |
Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo

Study Overview
=================
Brief Summary
-----------------
Patient with relapsing remitting multiple sclerosis taking avonex are included in this double blind randomized control trial. Simvastatin is compared to placebo. end points of edss , total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: simvastatin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: edss<5 >=1 attack in last year Exclusion Criteria: >2 attacks in study drug complication

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: simvastatin<br>* 40 mg/ day<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 80 mg /day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attack number |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
edss attack
Study Evaluating Impact of the Use of a Computer-based Tool on the Clinical Management of RA Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.

Official Title
-----------------
Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Review of clinical records


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Main Inclusion Criteria: Patients, male or female, over 18 years old. Patients diagnosed with RA according to investigator criteria Patients with a disease evolution >= 1 year Patients with > = 5 affected joints Exclusion Criteria: Exclusion Criteria: Patients with other muscle skeletal, rheumatic and/or degenerative diseases different from RA. Patients who are taking part or have taken part in a clinical trial or in a study with drugs within the last 12 months. Any condition that, in the investigator's judgment would interfere with the subject's ability to comply with protocol requirements or give informed consent.

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 |
| --- | --- |
| 1<br>Patients diagnosed with RA | Other: Review of clinical records<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global mean DAS28 at 6 and at 12 months of follow-up. Differences between global mean DAS28 at 6 and at 12 months compared to baseline |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity (DAS28; number affected joints; CRP; ESR; PGA).-Number of variables used in patient's follow-up; number of treatment adjustments. -Investigator's satisfaction with the computer-based tool (specific questionnaire) |  | 12 months |
Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims

Study Overview
=================
Brief Summary
-----------------
Effective Treatment of PTSD involves talking about the traumatic event in detail.It is unclear how this process influences the sensory-specific trauma network (fear structure)in the traumatized person. The goal of the project is to test the hypothesis that treatment-facilitated recovery does not change the original fear structure but establishes an inhibitory mechanism that depends on verbal activity. An affective visual steady-state paradigm in magnetencephalography (MEG) using positive, aversive and neutral picture stimuli will be used to examine the spatial and temporal pattern of the processing of emotional stimuli. To examine the effects of treatment this paradigm will be used as outcome measure within a randomized controlled trial of Narrative Exposure Therapy and a waiting-list control condition for severely traumatized torture victims.

Official Title
-----------------
Change of Neural Network Indicators Through Narrative Treatment of PTSD in Torture Victims

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Behavioral: NET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: experiences of organized violence/torture PTSD diagnosis Exclusion Criteria: psychotic disorder neurological disease or seizures current drug/alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: A<br>Narrative Exposure Therapy (NET) | Behavioral: NET<br>* Narrative Exposure Therapy for traumatized survivors of organized violence<br>|
| No Intervention: B<br>Waitinglist Control Group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) |  | 4 & 9 months after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| steady state visual evoked magnetic fields in response to affective stimuli |  | 4 & 9 months after completion of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, torture survivors, Narrative Exposure Therapy, trauma-related memory processes, steady state visual evoked fields
Collection of Anonymized Data for Improvement of Domestic Patient Monitor System

Study Overview
=================
Brief Summary
-----------------
Collection of anonymized data for improvement of domestic patient monitor system comparison of commercial patient monitor

Detailed Description
-----------------
the data from the patient will be collected as the baseline data for improvement of the domestic patient monitor system

Official Title
-----------------
Data Collection for Improvement of Domestic Patient Monitor

Conditions
-----------------
Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Other: MP 3000 monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical patients Exclusion Criteria: problem to monitor

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: MP 3000 monitor|Additional monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anoymized data collection | agreement of ECG data from the 2 different patient monitor | during surgery |
Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

Study Overview
=================
Brief Summary
-----------------
The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.

Official Title
-----------------
Assessment of Cytokine Profile in an Open Labeled Randomized Controlled Trial of Standard Dose vs. Once a Day Intravenous Albumin in Patients With Spontaneous Bacterial Peritonitis

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Drug: ALBUMIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SBP Age > 18 years Consent to participate in the trial Exclusion Criteria: Secondary peritonitis Malignancies including HCC

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STANDARD DOSE<br>Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3 | Drug: ALBUMIN<br>* Albumin in two different doses<br>|
| Placebo Comparator: LOW DOSE<br>Albumin 20g/d for 5 days | Drug: ALBUMIN<br>* Albumin in two different doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neutrophils/mm in ascitic fluid |  | 3 days | 
| Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in days at the end of therapy |  | 5 days | 
| Differences in frequency of sepsis, renal failure and other organ failures between the two groups |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, hepatitis B virus, Alcohol, varices
Ideal Sedation for Stroke Thrombectomy

Study Overview
=================
Brief Summary
-----------------
The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions whether sedation with intubation and paralytics is feasible and whether it delays the time to recanalization in comparison with conscious sedation alone. As a pilot registry, it is anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18 months. Following enrollment, data will be collected prospectively from medical records and from patients' visits.

Official Title
-----------------
Ideal Sedation for Stroke Thrombectomy

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Suitable for intra-arterial treatment for acute stroke up to 8 hours from onset of symptoms Clinical equipoise for best mode of sedation Exclusion Criteria: Any known allergy to either proposed medication and its alternative Any patient that has been intubated prior to randomization Posterior circulation strokes Age ≤ 18 Pregnant female

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 |
| --- | --- |
| Conscious Sedation/Monitored Anesthesia Care<br> | |
| General Anesthesia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval between groin puncture and final recanalization |  | 6 months or at study completion |
Primary vs. Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis a Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.

Detailed Description
-----------------
inclusion criteria: hinchey III and IV diverticulitis

Official Title
-----------------
Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial

Conditions
-----------------
Peritonitis

Intervention / Treatment
-----------------
* Procedure: Hartmann intervention
* Procedure: Protected anastomosis resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with peritonitis du to sigmoid diverticulum complication Surgeon - anesthetist confirming the 2 surgeries can be performed Exclusion Criteria: Physical state which can not permit patient to participate contraindication to surgery non-diverticulum peritonitis

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: 1<br>Surgery : Hartmann intervention | Procedure: Hartmann intervention<br>* sigmoid resection, peritoneal and rectal lavage, terminal stoma<br>|
| Experimental: 2<br>Surgery : primary resection with anastomosis with protective stoma | Procedure: Protected anastomosis resection<br>* sigmoid resection , peritoneal and rectal lavage, anastomosis, diverting stoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate comparison between two chirurgical strategies |  | 18 months |
Antioxidant Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: n-aceylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes - Exclusion Criteria: None, except known intolerance to n-acetylcysteine -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* one capsule BID<br>|
| Active Comparator: antioxidant drug<br>n-acetylcysteine | Drug: n-aceylcysteine<br>* 450 mgm BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes