linjc16/ctgov huggingface dataset:
Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis has a multifactorial etiology: aging, genetic, sex, weight, alimentation, injuries, infections etc. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the oxidative-antioxidative balance will be evaluated by determining markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.

Detailed Description
-----------------
A total of 300 patients with osteoarthritis will be included in the study. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the weight and height of each patient will be assessed and the patients will be included in 4 classes based on the body mass index: underweight, normal weight, overweight and obese. The type of physical activity will also be noted and the oxidative-antioxidative balance will be evaluated by determining serum markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde. Correlation between eating behaviour, body mass index and oxidative stress markers will be made.

Official Title
-----------------
Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: Questionnaire of eating habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis signed informed consent Exclusion Criteria: drugs or foods with antioxidant effects lack of judgement refuse to participate
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteoarthritis<br>Questionnaire of eating habits, markers of oxidative stress | Other: Questionnaire of eating habits<br>* frequency and type of aliments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum concentration of oxidative stress markers | oxidated glutathione/reduced glutathion, catalase enzyme, superoxide dismutase, glutathion peroxidase, malonyldialdehyde | baseline |
Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Iodine I 131 Tositumomab

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations consisting of a TSH level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.

Official Title
-----------------
A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH IODINE I 131 TOSITUMOMAB IN STUDIES CP-97-011, CP-98-025, CP-99-032, or CP-99-036

Conditions
-----------------
Lymphoma, Non-Hodgkin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have enrolled in one of the following Corixa sponsored clinical trials: CP-97-011, CP-98-025, CP-99-032, or CP-99-036 and are >2 years post treatment with Iodine I 131 Tositumomab. Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study. Exclusion Criteria: Inability to meet above referenced inclusion criteria.

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 |
| --- | --- | --- |
| long term followup data | safety and efficacy data will be presented as follow up data with updates to studies 104505, 393229/023, 393229/007, 104514 and 393229/028. | every 3 months at Months 6, 9, 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-Term Follow-up, BEXXAR, Iodine I 131 Tositumomab, Low-grade lymphoma
SureScan Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.

Conditions
-----------------
Bradycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication Exclusion Criteria: Subject who is, or will be inaccessible for follow-up Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable Subject with exclusion criteria required by local law
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Performance<br>Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months. | |
| Multiple MRI Scan Characterization<br>Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Related Complication Rate |  | 5 years | 
| Lead Related Complication Rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in pacing thresholds after multiple MRI scans |  | 5 years | 
| Summarize MRI system and scan conditions |  | 5 years | 
| Pacing system related events |  | 5 years | 
| Characterize lead impedance |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MR conditional
Follow-Up Study of Patients Previously Treated With Pimecrolimus Tablets for Chronic Plaque-Type Psoriasis

Study Overview
=================
Brief Summary
-----------------
This extension study is being conducted to collect post-treatment safety information on patients who previously participated in the core clinical trial.

Official Title
-----------------
A Follow-Up Study of Patients Previously Treated in a Core Study With Pimecrolimus Tablets for Chronic Plaque-Type Psoriasis

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting patients who participated in the core clinical trial

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, psoriasis, adverse event, SAE, extension
Comparing Interactive and Non-interactive CD-based Method

Study Overview
=================
Brief Summary
-----------------
Using different methods of electronic learning has been increasingly developed by emerging electronic educational technologies. They could apply on the net, CDs, Mobile, etc in different usage alternatives: interactive and non-interactive both in online and off-line approaches. In this educational trial, the interactive and non-interactive CD-based method for teaching medical terminology to nursing students of MUMS school of nursing and Midwifery during 2009-2012 was compared.

Official Title
-----------------
Comparing Interactive and Non-interactive CD-based Method in Teaching Medical Terminology

Conditions
-----------------
Interactive CD-based Education

Intervention / Treatment
-----------------
* Other: teaching by non-interactive CD
* Other: Interactive CD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing students studying in MUMS school of nursing and passing Medical Terminology Exclusion Criteria: any other discipline, students of other schools
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: coventional group<br>Teaching just by book | |
| Experimental: non-interactive CD<br>Teaching book with non-interactive CD | Other: teaching by non-interactive CD<br>* teaching book with non-interactive CD<br>|
| Experimental: interactive CD<br>Teaching book with interactive CD | Other: Interactive CD<br>* Teaching book with interactive CD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| students' mean Scores | the outcome mesures will be completed up to 6 months | up to three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elearning, CD-based education
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

Official Title
-----------------
A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

Conditions
-----------------
Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease

Intervention / Treatment
-----------------
* Device: CardiAQ TMVI System (Transapical DS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: NYHA Classification ≥ III Left Ventricular Ejection Fraction ≥ 30% Mitral regurgitation ≥ Grade 3+ Subject meets anatomical eligibility criteria for the investigational device

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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: CardiAQ TMVI System (Transapical DS)<br> | Device: CardiAQ TMVI System (Transapical DS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Major Adverse Event Rate |  | 30-Day | 
| Composite Major Adverse Event Rate |  | 12-Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical
A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids

Study Overview
=================
Brief Summary
-----------------
This study will characterize the treatments and outcomes associated with different uterine fibroid treatments in Canada, to understand patients' preferences and satisfaction with different medical and procedural interventions. The study will also assess the effectiveness of ulipristal acetate (Fibristal®) in controlling bleeding, reducing fibroid volume and symptoms, and improvement in patient's quality of life.

Official Title
-----------------
A Multicentre Prospective Non-interventional Study Assessing the Management of Canadian Women With Uterine Fibroids, a Patient Registry

Conditions
-----------------
Leiomyoma

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Pre-menopausal adult women with confirmed diagnosis and symptoms associated with uterine fibroids who are initiating treatment. Exclusion Criteria: -Significant pelvic pathology not associated with uterine fibroids.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Female patients who are diagnosed and treated for symptoms associated with their uterine fibroids per routine clinical practice. No intervention is administered in this study. | Other: No Intervention<br>* No intervention is administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL) |  | 24 Months | 
| Ruta Menorrhagia (Bleeding) 15-Item Questionnaire |  | 24 Months | 
| Number of Participants with Adverse Drug Reactions |  | 24 Months |
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.

Official Title
-----------------
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue

Conditions
-----------------
Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Olmesartan
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained Male and female subjects aged 20 years or older at informed consent Essential hypertension who had never received angiotensin II receptor antagonists and calcium channel blockers Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus History or evidence of a stroke Hepatic or hematologic abnormality Mild Cognitive Impairment or Dementia Serum potassium level ≥ 5.5 mEq/L Serum creatinine level ≥ 3.0 mg/dL Acute or chronic disease Allergy to any drugs Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Olmesartan<br>Olmesartan 10-40mg daily | Drug: Olmesartan<br>* 10-40mg daily<br>|
| Active Comparator: Amlodipine<br>Amlodipine 2.5-10mg daily | Drug: Amlodipine<br>* 2.5-10mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT |  | 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio (TBR) by FDG-PET/CT |  | 6 months of treatment | 
| Change from baseline in abdominal and muscle fat volume as measured by CT |  | 6 months of treatment | 
| Change from baseline in circulating inflammatory markers including hsCRP (mg/L), adiponectin (µg/mL), ADMA (nmoL/mL), DPP-4 (ng/mL), advanced glycation end products (AGEs, µg/mL) and angiotensin-(1-7) (ng/mL) |  | 6 months of treatment |
COVID-19 and ICU-acquired MDR Bacteria

Study Overview
=================
Brief Summary
-----------------
This multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.

Detailed Description
-----------------
Multicenter observational before-after study, aiming to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired colonization and infection related to MDR bacteria.

Official Title
-----------------
Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria

Conditions
-----------------
Sars-CoV2, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Expected ICU stay > 48 hours Rectal and nasal BMR screening performed < 48 hours after admission to ICU Exclusion Criteria: Patients aged < 18 years Refusal to take part in the study ICU-stay < 48 hours At least a second rectal and nasal BMR screening was not performed prior to ICU discharge (a posteriori exclusion criterion).

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 |
| --- | --- | --- |
| Cumulative incidence of ICU-acquired colonization related multidrug resistant bacteria | percentage of patients with ICU acquired MDR bacteria colonization | from D3 until day 28 after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of ICU-acquired infection related to multidrug resistant bacteria | percentage of patients with ICU acquired MDR bacteria infection | from D3 until day 28 after ICU admission | 
| Mechanical ventilation duration | the number of days Under mechanical ventilation | from D1 until day 28 after ICU admission | 
| mortality | death in the ICU | from D1 until day 28 after ICU admission | 
| length of stay in intensive care unit | the number of days of hospitalization in the ICU | from D1 until day 28 after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, Critically ill patients, multidrug-resistant bacteria, infection, colonization
Ondansetron for the Treatment of Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.

Detailed Description
-----------------
Double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine dependence and to determine the optimal dose of ondansetron.

Official Title
-----------------
Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders, Drug Administration Schedule

Intervention / Treatment
-----------------
* Drug: Ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female, at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; seeking Treatment for cocaine dependence; have ability to understand, having understood and provide written consent; females of child bearing potential that use accepted method of birth control Exclusion Criteria: Additional criteria available during screening at the site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Ondansetron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine use |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence