linjc16/ctgov huggingface dataset:
Synaptic Plasticity Imaging With Diffusion MRI

Study Overview
=================
Brief Summary
-----------------
Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical (venography, tractography by diffusion) features in young and aged subjects.

Detailed Description
-----------------
This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging (DWI) of the brain : functional imaging using DWI and BOLD anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used anatomical imaging like T1 maps and susceptibility-based maps. First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was explored to obtain activation of brain following visual stimulations. These modality was compared to BOLD and anatomical venography. The DWI exams for anatomical (tractography) used both high angular resolution directional diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain precise knowledge about tissue microstructure. Study was approved by the National French Institute of Health and by french organism for biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to aged healthy people (60-80 years). Then, anatomical studies are devoted to obtain microstructures information about brain areas that are changed with age, and to validate fully the feasibility of the DfMRI approach.

Official Title
-----------------
Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI

Conditions
-----------------
Brain Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 20-30 years 60-80 years Exclusion Criteria: psychological or organic trouble

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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
-----------------
age, microstructure, diffusion MRI
A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR formulation.

Official Title
-----------------
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases In Japan Adults

Conditions
-----------------
Acute Bronchitis

Intervention / Treatment
-----------------
* Drug: Azithromycin SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as mild or moderate in severity by the classification of infection of the Japanese Society of Chemotherapy guidelines for the evaluation methods of new antibacterial drug (established in 1997). Exclusion Criteria: Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is investigator's clinical efficacy at Day 8. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 15 and 29), and the tendency toward clinical improvement (at Day 4); Bacteriological efficacy (at Day 4, 8, 15 and 29); Safety Endpoints: Adverse events and safety lab data. |  |  |
Comparison of stAndard and Hybrid Surgical Techniques in the Treatment of proximaL Aortic dissEctions

Study Overview
=================
Brief Summary
-----------------
The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.

Official Title
-----------------
Comparison of Standard and Hybrid Techniques in Surgical Treatment of Proximal Aortic Dissection

Conditions
-----------------
State of Non-operated Aortic Segments, Aorto-related Events

Intervention / Treatment
-----------------
* Procedure: aortic prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic dissection type A Exclusion Criteria: age limits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Frozen elephant trunk surgery<br> | Procedure: aortic prosthesis<br>* ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis<br>|
| Standart surgery<br> | Procedure: aortic prosthesis<br>* ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aorto-related events | Death, reoperations,thoracoabdomminal aneurysms | 3 years |
Screening Protocol to Evaluate Acid Alpha-Glucosidase (GAA) Activity and GAA Gene Mutations in Patients With Late Onset Pompe Disease

Study Overview
=================
Brief Summary
-----------------
Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The primary objective of this study is to identify potential candidates for future clinical studies in Pompe disease.

Official Title
-----------------
Screening Protocol to Evaluate Acid Alpha Glucosidase (GAA) Activity and GAA Gene Mutations in Patients With Late Onset Pompe Disease for Potential Inclusion in Future Clinical Studies With Myozyme (Alglucosidase Alfa)

Conditions
-----------------
Pompe Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must provide written informed consent prior to any study-related procedures being performed Clinical presentation consistent with late-onset Pompe disease, or a current clinical diagnosis of late-onset Pompe disease Must be greater than or equal to 8 years of age Must be able to ambulate (use of assistive devices, such as a walker, cane or crutches, is permitted) Exclusion Criteria: Requires the use of invasive ventilatory support Requires the use of noninvasive ventilatory support while awake and in an upright position Use of any investigational product within 30 days prior to study enrollment Unwillingness to comply with protocol requirements Has clinically significant organic disease, unstable medical condition, serious or intercurrent illness Is pregnant or lactating Has participated in the Prospective Observational Study in Patients with Late-Onset Pompe Disease (AGLU02303, LOPOS)

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Patients with late onset Pompe Disease<br> | |

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
-----------------
Glycogen Storage Disease Type II, GSD-II, Pompe Disease, Pompe Disease (Late-Onset), Glycogen Storage Disease Type II (GSD-II), Acid Maltase Deficiency, Glycogenosis 2
Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care

Study Overview
=================
Brief Summary
-----------------
The cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of Cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a literature mainly based on American data and which focuses particularly on ischemic heart disease. The expected results are to have a prevalence of PAOD in an Alsatian cohort, most of the data we currently have from American data, with analysis of the impact of specific and non-specific risk factors in this cohort and their weight in PAOD.

Official Title
-----------------
Study of the Prevalence of Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care

Conditions
-----------------
PAOD - Peripheral Arterial Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult woman (≥18 years old) Patient hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive Patient who did not express her opposition to the reuse of her data for scientific research purposes. Exclusion criteria: Patient who expressed her opposition to participating in the study Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, MMS <20/30…) Non-type 1 or unconfirmed myocardial infarction Unstable or refractory shock state at the time of the echodoppler examination Complication of the coronary angiography approach, in the case of femoral approach only, requiring surgical management. Patient under curatorship, guardianship or judicial safeguard.

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

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

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 |
| --- | --- | --- |
| Study of the prevalence of peripheral artery occlusive disease (PAOD) |  | Files analysed retrospectively from January 01, 2021 to Jun 30, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Arterial Occlusive Disease, PAOD, Cardiovascular risk factors, Myocardial infarction
Combined Afib Ablation and RA Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform renal artery denervation at the same time as atrial fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a successful atrial fibrillation ablation, and decrease the number of medications required to control blood pressure.

Official Title
-----------------
Combined Atrial Fibrillation Ablation and Renal Artery Denervation for the Maintenance of Sinus Rhythm and Management of Resistant Hypertension

Conditions
-----------------
Afib, Hypertension

Intervention / Treatment
-----------------
* Procedure: Renal Artery denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients scheduled for afib ablation Patient taking one or more BP medication Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Combined afib ablation and RA denervation<br>Patients with atrial fibrillation and resistant hypertension will be enrolled and undergo a single procedure consisting of pulmonary vein isolation and renal artery denervation. | Procedure: Renal Artery denervation<br>* RA denervation performed as part of afib ablation procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systolic blood pressure when measured at routine 1 and 3 month follow up appointments |  | 1 to 3 months |
Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone

Study Overview
=================
Brief Summary
-----------------
To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2 spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients suffering from first-episode schizophrenia/schizophreniform disorder.

Official Title
-----------------
A Randomized, Double-Blind, Crossover Add-On Study To Assess The Differential Sensitivity Of 2 Spatial Working Memory Tests (The Groton Maze Learning Test [GMLT] And The Motor Delayed Response Test [MDR]) In Non-Agitated, Antipsychotic Drug-Naive First-Episode Schizophrenic Or Schizophreniform Patients Treated With Risperidone 2 Mg Daily Or Placebo

Conditions
-----------------
Schizophrenia, Psychotic Disorders

Intervention / Treatment
-----------------
* Drug: Risperidone 2 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 to 50 years old, antipsychotic-naive, non-agitated patients diagnosed with first-episode schizophrenia or schizophreniform disorder. Exclusion Criteria: Evidence or history of clinically significant medical or non-medical impairment that, in the opinion of the investigator, would affect the safety of the patient or interfere with the evaluation of the trial results; Patients who have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug on the Screening urine toxicology test Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risperidone 2 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional descriptive analyses: Change from baseline in ESRS, PANSS, SOFAS, SRDEQ, and AVM on D8+15; CGI-C on D8+15 |  |  | 
| -Change from baseline in GMLT, ODR, ESRS, PANSS, SOFAS, SRDEQ, AVM on D43; CGI-C on D43 |  |  | 
| -ESRS will also be performed on D4+11 |  |  |
Community Based Exercise Program for Well Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
This project will create a community based exercise program for well cancer survivors. The goal is that the YMCA will gain the competence to work with this unique population in a safe and productive manner.

Detailed Description
-----------------
All well, adult, cancer survivors are eligible to participate.

Official Title
-----------------
CanWell: YMCA Based Exercise Program for Well Cancer Survivors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All well cancer survivors who are medically stable. Exclusion Criteria: Children are not eligible for this project.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>All participants will take part in a supervised, structured, exercise program | Other: Exercise program<br>* All exercise programs will include endurance and strength exercises.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance measure (STEEP treadmill test) |  | Within one week before initiating the exercise program | 
| Endurance measure (STEEP treadmill test) |  | Administered at 6 weeks of the exercise program | 
| Endurance measure (STEEP treadmill test) |  | Administered at 12 weeks (end of) the exercise program | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Oncology, Rehabilitation, Endurance, Strength
A Phase 1 Parallel-Group, Double-Blind, Placebo-Controlled Cardiovascular and Behavioral Study Assessing Interactions Between Single Doses of Oral Reserpine and Intravenous Methamphetamine - 1

Study Overview
=================
Brief Summary
-----------------
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.

Detailed Description
-----------------
In this parallel group clinical pharmacology laboratory experiment, we will assess pharmacodynamic interactions (with a focus on cardiovascular effects) of a 15 mg intravenous methamphetamine dose and single oral doses of reserpine (0.5 and 1.0 mg) or placebo.

Official Title
-----------------
Assessment of Interactions Between IV Methamphetamine and Reserpine

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Reserpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Please contact site for more details Exclusion Criteria: Please contact site for more details

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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: Reserpine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Cardiovascular |  |  | 
| Subjective symptoms/Mood Effects |  |  | 
| CNS norepinephrine turnover |  |  |
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.

Detailed Description
-----------------
The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated. This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.

Official Title
-----------------
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses

Conditions
-----------------
Corneal Astigmatism

Intervention / Treatment
-----------------
* Device: enVista Toric
* Device: enVista non-Toric (spherical)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females subjects age 18 or older on the date of surgery Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye Data available at least 4 weeks after IOL implantation Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator) Study eyes were implanted with the 0.9D toric lens Control eyes were not implanted with the 0.9D toric lens and implanted with a spherical (non-toric) equivalent instead Exclusion Criteria: History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.) BCDVA of 20/25 or worse for the treated eye(s) after the surgery Excessive IOL rotation > 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery

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 |
| --- | --- |
| enVista Toric 0.9D intra ocular lens<br> | Device: enVista Toric<br>* enVista Toric IOL<br>|
| enVista non-Toric (spherical) intra ocular lens<br> | Device: enVista non-Toric (spherical)<br>* enVista non-Toric (spherical) IOL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in cylindrical power of the eye | Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane). | 4 weeks after IOL implantation |