linjc16/ctgov huggingface dataset:
The VOICE-COVID-19

Study Overview
=================
Brief Summary
-----------------
The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.

Detailed Description
-----------------
This study is an open-label, prospective, cross-over randomized study. VOICE-COVID I: All individuals entering the Heart Failure (HF) Clinic of the McGill University Health Center will be asked to participate. A poster with instructions to ask the participants (employees or patients) to speak with the Amazon Alexa device. The participant will remain 6 feet away from the device. The Amazon Alexa will ask the survey questions. A study coordinator will then ask the same questions along with some additional questions about Amazon Alexa usability. VOICE-COVID II: A second cohort of 52 people will be then randomized to be screened for symptoms of COVID-19 with an Amazon Alexa or a coordinator. We will study the correlation between the Alexa response and the response to the study coordinator using K-squared statistic tests and screening question concordance.

Official Title
-----------------
Voice-based Identification of Clinical Features Requiring Emergent Action in Patients With Suspected COVID-19 Infection (VOICE-COVID) I and II Study

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: Alexa Amazon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >=18 yrs who is entering the HF clinic Speaks either English or French 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 |
| --- |
|Device: Alexa Amazon|To test the use of the Amazon Alexa device as a tool to conduct screening of employees and patients at the point of entry into the Heart Failure (HF) Clinic of the McGill University Health Center.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between data captured using Amazon Alexa compared to manual (human) collected data. | Determine the ability of the Amazon Alexa device to properly capture answers from participants and correlate with the answers retrieved by the study coordinator. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Alexa Device, Voice-based technologies, Screening, Safety
Transverse Myelitis Related to SARS-CoV-2 Vaccines

Study Overview
=================
Brief Summary
-----------------
Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce. The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed Description
-----------------
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.

Official Title
-----------------
Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database

Conditions
-----------------
Vaccine Adverse Reaction

Intervention / Treatment
-----------------
* Drug: SARS-CoV-2 vaccines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction, Exclusion Criteria: chronology not compatible between the SARS-CoV-2 vaccine adminisration and onset of TM. vaccines non-labelled by FDA/EMA (data cutoff december 10, 2021)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SARS-CoV-2 vaccines|All patients treated at least with 1 SARS-CoV-2 vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TM reportes related to SARS-CoV-2 vaccine |  | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the latency period since SARS-CoV-2 vaccine exposure. |  | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 | 
| Description of the outcomes following TM |  | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 | 
| Description of patients who experienced co-reported adverse events |  | date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021 |
Constipation Fiber Trial

Study Overview
=================
Brief Summary
-----------------
This study examines the effects of dietary fiber in the treatment of functional childhood constipation.

Detailed Description
-----------------
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency. All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.

Official Title
-----------------
Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation

Conditions
-----------------
Functional Constipation in Children

Intervention / Treatment
-----------------
* Other: Fiber
* Other: Fiber
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2-16 years of age with functional constipation as defined based on the Rome III criteria Exclusion Criteria: Constipation attributable to organic and anatomic causes or intake of medication Children who had previous surgery of the colon or anus History of allergy/intolerance to components of snack bar (e.g. celiac disease)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber 1<br>Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks | Other: Fiber<br> <br> * Other names: Single fiber type;|
| Experimental: Fiber 2<br>Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks | Other: Fiber<br> <br> * Other names: Blend of fiber types;|
| Placebo Comparator: Placebo<br>Bar with low fiber content (placebo) once daily for 4 weeks | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stool frequency |  | 4 weeks | 
| Change in stool consistency | Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end | 4 weeks |
Intravitreal Ranibizumab in Recurrent ROP

Study Overview
=================
Brief Summary
-----------------
A retrospective study included reviewing of medical records of preterm babies who were admitted in neonatal intensive care unit (NICU) of Mansoura University children hospital (MUCH) or referred from nearby hospitals for ROP screening during the period from March 2013 to February 2020.

Detailed Description
-----------------
Retinopathy of prematurity was diagnosed and classified according to the International Classification of ROP. Data of the patients who received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) were collected. Intravitreal ranibizumab injection was performed as follows; topical anesthetic drop was applied, standard aseptic eye preparation with 5% betadine was performed, a lid speculum was inserted and intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus was given. In case of bilateral ROP, both eyes are injected in the same session. Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed. ROP reactivation was defined as any of the following: recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment . Once recurrence was determined, second injection of IVR (0.25mg/0.025mL) was given to patients or surgery was performed if progressed to stage 4 or 5. All treated infants were examined until complete regression of ROP and full retinal vascularization.

Official Title
-----------------
Clinical Outcome Following Reinjection of Ranibizumab in Recurrent Cases With Retinopathy of Prematurity

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Drug: intravitreal injection of Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) and developed recurrence of ROP Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intravitreal injection of Ranibizumab|intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| full vascularization of the retina | Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed. | 6 months |
Metformin in Breast Cancer, Visualized With Positron Emission Tomography

Study Overview
=================
Brief Summary
-----------------
The general purpose of the trial is to investigate whether metformin is taken up into the breast tumor. Studies in the last few years have shown an effect of metformin on cell proliferation on breast cancer. It is though unclear whether the effect on tumor is direct, indirect or a combination of the two. The investigators plan to: investigate if metformin is taken up in breast cancer using our novel 11C-metformin tracer and positron emission tomography (PET) investigate whether the uptake is correlated to the amounts of organic cation transporters (OCT1-3, MATE 1 &2 and PMAT) using quantitive polymerase chain reaction (qPCR).

Official Title
-----------------
Metformin in Breast Cancer, Visualized With Positron Emission Tomography

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: 11C-metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 50 years C. mammae Tumor size: > 10 mm in diameter Unilateral cancer WHO performance status 0-1 Exclusion Criteria: Severe heart- or kidney failure Pregnant or breast feeding If the patient is found not eligible for participation in the study på principal investigator

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 11C-metformin uptake in breast cancer. Single center, single dose, open-label.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 11C-metformin<br>All participants allocated to the study will be included in this arm | Radiation: 11C-metformin<br>* 400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin uptake in breast cancer |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Pharmacokinetics, Organic cation transporter, Multidrug and toxin extrusion, Pharmacogenetics, positron emission tomography
The Study of Polycystic Ovary Syndrome (PCOS) and Questionnaire

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.

Official Title
-----------------
The Study of Polycystic Ovary Syndrome (PCOS) and Questionnaire

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women at reproductive age women with PCOS and women without PCOS Exclusion Criteria: young women who had their menarche less than 3 years women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Polycystic Ovary Syndrome.<br>Polycystic ovary syndrome was diagnosed according to the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria: PCOM, chronic anovulation and hyperandrogenism. | |
| Normal Control<br>Normal control women were women who did not present with any of three PCOS criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity is the predominant predictor of impaired glucose tolerance and metabolic disturbance in polycystic ovary syndrome. | To evaluate the contribution to glucose intolerance and metabolic syndrome of obesity combined with the diagnostic criteria of polycystic ovary syndrome (PCOS). | Prospectively study in University teaching hospital from 31 August 2010 to 31 August 2011. |
CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.

Detailed Description
-----------------
This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will be enrolled.

Official Title
-----------------
A Phase 1, Randomized, Open-label, Single-dose, Two-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of the Pre-filled Syringe and Auto-injector of CT-P13 in Healthy Subjects

Conditions
-----------------
Health, Subjective

Intervention / Treatment
-----------------
* Biological: CT-P13 SC Auto-injector
* Biological: CT-P13 SC Pre-filled Syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subject Subject voluntarily agrees to participate in this study Exclusion Criteria: Subject with medical history and/or condition Female who is pregnant or breastfeeding, or childbearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P13 SC Auto-injector<br>CT-P13 SC Auto-injector | Biological: CT-P13 SC Auto-injector<br>* Each subject may receive single dose by subcutaneous administration using Auto-Injector<br>|
| Experimental: CT-P13 SC Pre-filled Syringe<br>CT-P13 SC Pre-filled Syringe | Biological: CT-P13 SC Pre-filled Syringe<br>* Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects. | Pharmacokinetics will be assessed by AUC | over 12 weeks |
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.

Conditions
-----------------
Cervical Ripening

Intervention / Treatment
-----------------
* Device: Cook catheter
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy reassuring fetal status at time of presentation Bishop Score <6 Exclusion Criteria: Closed cervix Breech presentation Multiple gestations Recent vaginal bleeding Placenta previa non reassuring fetal status Active genital herpes infection

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cook catheter<br>Control | Device: Cook catheter<br> <br> |
| Active Comparator: Cook catheter plus low dose oxytocin<br>Test group | Device: Cook catheter<br> <br> Drug: Oxytocin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Delivery (in Hours) | Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6) | Up to 60 hours |
Educational and Cultural Engagement and Incidence of Health Adverse Events

Study Overview
=================
Brief Summary
-----------------
This study evaluated if the social and cultural activities decrease the incidence of dementia and frailty conditions.

Detailed Description
-----------------
The past decade has been characterized by the involvement of Museums in individual health prevention and promotion by using art-based activities to improve quality of life and well-being. Visiting museum or over cultural and educational activity could be used for health prevention and promotion. For the development of appropriate educational and cultural activities, there is a need, first, to improve knowledge about social and health condition of older adult, and second to examine the effects of engagement in educational and social activity on incidence of health adverse events.

Official Title
-----------------
Educational and Cultural Engagement and Incidence of Health Adverse Events: Results From the Canadian Longitudinal Study on Aging

Conditions
-----------------
Older Adults, Depression, Cognitive Decline

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 50 years and over Being enrolled in the Canadian Longitudinal Study on Aging Actively involved in social and cultural activities Exclusion Criteria: Never enrolled in the Canadian Longitudinal Study on Aging Less than 50 years old

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational|Participants who attended different educational and cultural activities either in a community centers or public institutions like arts museums or universities.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | It will be used the Depression scale which has a score of 10 or less. Each participant will be asses based on this scale. The depression scale evaluates the depression symptoms for a time period. | around 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motoric cognitive risk syndrome | Motoric cognitive risk syndrome represents a pre-dementia syndrome characterized by cognitive complaints and a slow gait speed. | around 20 years |