linjc16/ctgov huggingface dataset:
Detection of Topographic Residual Acuity in Patients With Age Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Standard perimetry provides information on topographical retinal sensitivity to light stimuli, however the said locus is not necessarily the preferred locus for fixation. Standard perimetry could also be used as a way for macular scotoma mapping, indirectly showing the fixation locus. Topographic acuity at the preferred retinal locus can be determined if correlation between loci with high sensitivity, eccentric fixation loci and potential visual acuity measurements are correlated. PURPOSE OF THE STUDY: Determination of visual acuity at preferred retinal locus in Low Vision patients with ARMD using eye standard automated and computerized perimetry methods.

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: perimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AMD with documented pathology Low Vision both eyes BCVA 20/50-20/400 in best eye Exclusion Criteria: Cognitive impairment Other retinal pathology Previous retinal surgery Significant media opacity
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: perimetry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of eccentric retinal locus of highest fixation accuracy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location of eccentric locus with best retinal sensitivity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age-related macular degeneration, preferred retinal locus, macular perimetry
Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy

Study Overview
=================
Brief Summary
-----------------
Given that previous studies demonstrated the feasibility of the required MRI techniques, we propose to study the macro- and microvascular adaptations in PAOD patients undergoing supervised exercise therapy. It is expected to provide valuable insights into the contribution of each vascular mechanism to the rehabilitation and to identify which vascular mechanism fails or is insufficient for a successful rehabilitation. Improvement of future treatment requires the identification of relevant adaptive mechanisms. With this we will provide early noninvasive MRI readout tools to diagnose and monitor the potential rehabilitation during any form of therapy for PAOD that affects the peripheral vasculature.

Official Title
-----------------
Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy: a MRI Study

Conditions
-----------------
PAOD (Peripheral Arterial Obstructive Disease)

Intervention / Treatment
-----------------
* Other: supervised treadmill exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermittent claudication according to a positive Rose-Edingburgh questionnaire Rest ankle-brachial pressure index (ABPI) < 0,90 or 10% decline in ABPI after exercise Arterial stenosis/occlusion of femoro-popliteal territory according to duplex/MRA measurements Able to ondergo exercise therapy Exclusion Criteria: Chronic or acute critical ischemia Treated by or planned for vascular surgery or percutaneous transluminal angioplasty Recent onset <2 months Unable to perform treadmill exercise Diabetes mellitus Contra-indications for (Gadolinium-enhanced) MRI or thigh cuff inflation

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 referred to the vascularsurgeon with complaints of claudication for their first time, will be asked to participate with the study, with respect toward the in- and exclusion criteria. | Other: supervised treadmill exercise program<br>* Supervised treadmill therapy consists of a walking exercise on a treadmill under supervision of a physiotherapist, 2-3 times a week. This program is combined with individual walking every other day and the total duration of the program is 6 months. Guided by the painfree walking distance, every month the angle and/or speed of the treadmill will increase. A standardized protocol for this type of therapy is already in use by many physiotherapists in Limburg (Willigendael, 2005).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases

Study Overview
=================
Brief Summary
-----------------
Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.

Official Title
-----------------
Diagnostic Comparison and Workflow Evaluation of Whole Body PET-magnetic Resonance and PET-CT With and Without Contrast Media in Patients With Oncologic Diseases

Conditions
-----------------
Neoplasm Staging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients from 18-90 years Written informed consent Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media Exclusion Criteria: Pregnant or breast feeding women Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia) Inclusion in another clinical trial 30 days prior to inclusion Age < 30years Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia Known allergies to contrast CT or MRI contrast media Patients with an glomerular filtration rate of < 60ml/min/1.73m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT |  | 12 month |
Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture

Study Overview
=================
Brief Summary
-----------------
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.

Conditions
-----------------
Port-site Hernia

Intervention / Treatment
-----------------
* Procedure: Prophylactic mesh placement
* Procedure: Fascial suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 65 years BMI > 30 Kg/m2 Diabetes mellitus Lung disease Elective laparoscopic cholecystectomy Exclusion Criteria: Umbilical hernia Previous laparotomy Conversion to open procedure Loss during the follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture<br>Umbilical port-site closure with simple suture of the fascia. | Procedure: Fascial suture<br>* The port-site hole is closed with simple suture of the fascia<br>|
| Experimental: Prophylactic mesh<br>Umbilical port-site closure with mesh placement | Procedure: Prophylactic mesh placement<br>* Placement of a Omega 3 mesh, fixed to the border of the fascia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of port-site hernia | Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Evaluation of different pain perception in patients with and without prophylactic mesh placement, determined in the postoperative course and at 1, 6 and 12 months after surgery | 12 months |
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station

Study Overview
=================
Brief Summary
-----------------
The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition.

Official Title
-----------------
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station

Conditions
-----------------
Urinary Tract Infection, Diabetes Mellitus, Atrial Fibrillation, OSA, COPD, Pneumonia, Acute Otitis Media, Leukocytosis, Iron Deficient Anemia, Hypertension, Healthy Volunteers

Intervention / Treatment
-----------------
* Device: Vitaliti


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years of age. English speaking Established diagnosis of one of the thirteen required conditions with evidence in Medical Record. Exclusion Criteria: Lack of patient consent Has pacemaker or internal medical device Pregnancy Concurrent enrollment into a clinical trial that may affect subject treatment Age less than 18 or over 65 Physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Vitaliti System<br> | Device: Vitaliti<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record |  | 90 minutes |
A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment

Official Title
-----------------
A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history Painful physical symptoms as measured by the Brief Pain Inventory-Short Form Exclusion Criteria: Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia) Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders

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

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Efficacy by the following: MADRS total score, time to sustained clinical response for painful physical symptoms, time to sustained clinical response for overall depression symptoms, SCL-90R scale, PGI-I, CGI-S, CGI-I and BPI-SF. |  |  | 
| Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values. |  |  |
Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-CoV-2 Infection (COVID-19)

Study Overview
=================
Brief Summary
-----------------
Establishment of a biological bank of subjects vaccinated against SARS-Cov-2 infection (COVID-BioVac)

Detailed Description
-----------------
The purpose of the COVID-BioVac study is to establish a biobank of biological samples from subjects who have received the anti-SARS-CoV-2 vaccine, with the ultimate aim (following approval by the EC of specific substudies) to study and characterize the antiviral immune response generated following anti-SARS-CoV-2 vaccination. To this end, the COVID-BioVac Biobank will be officially established for the collection and storage of human biological material, non-profit, to support research activities aimed at advancing scientific knowledge, including in the genetic field, on the immune response. vaccination-induced anti-SARS-CoV-2.

Official Title
-----------------
Establishment of a Biological Biobank of Subjects Vaccinated Against SARS-Cov-2 Infection (COVID-BioVac)

Conditions
-----------------
Coronavirus Infections

Intervention / Treatment
-----------------
* Other: biological bank


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Who have vaccinated for SARS-CoV-2 with Pfizer-BioNTech vaccine or others Signing of informed consent from January to March 2021 Exclusion Criteria: none

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 |
| --- |
|Other: biological bank|biological bank of subjects vaccinated against SARS-CoV-2 infection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 vaccines response | Create a Biobank to evaluate the immunogenicity of COVID-19 vaccines in terms of antibody titers | from Day 1 of first vaccination up to 1 years after the last vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biobank, SARS-CoV-2, COVID-19
Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

Study Overview
=================
Brief Summary
-----------------
This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

Official Title
-----------------
An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: VI-0521


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed the qualifying DM-230 trial If females of child-bearing potential, subjects must be using adequate contraception Provide written informed consent Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures Be greater than 80% compliant in study medication use during the last three visits for DM-230 Exclusion Criteria: Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16-Week population<br>Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) | Drug: VI-0521<br>* Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks<br>|
| Experimental: 72-Week population<br>Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) | Drug: VI-0521<br>* Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline to Week 72 |  | Baseline to 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Change From Baseline to Week 72 |  | Baseline to 72 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Type 2 Diabetes, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Glycemic Control
Ventilation in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

Detailed Description
-----------------
This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).

Official Title
-----------------
International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery

Conditions
-----------------
Respiratory Complication, Respiration, Artificial, Anesthesia, General, Bypass, Cardiopulmonary

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive cardiac surgery patients with CPB during one predefined period, Elective or urgent surgery as defined by EuroSCORE2. Exclusion Criteria: Refusal of consent, Pregnant women, Age < 18 years, Heart transplant, ECLS, ventricular assist Emergency or salvage surgery as defined by EuroSCORE2

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 |
| --- | --- |
| Cohort<br>An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria. | Other: Survey<br>* An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.<br>* Other names: not adapted;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight) | percent | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of using positive end-expiratory pressure | (PEEP)> 5 cmH2O | 1 day | 
| incidence of using at least 2 alveolar lung recruitment manoeuvres | percent | 1 day | 
| incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres | percent | 1 day | 
| incidence of postoperative pulmonary complications | percent | 1 month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pulmonary complications, Protective mechanical ventilation, Alveolar lung recruitment manoeuvres, Cardiac Surgery Procedures