linjc16/ctgov huggingface dataset:
Clinical Outcomes of Pregnant Individuals With Epilepsy - Prospective Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the pregnancy, delivery, neonatal, and epilepsy outcomes in individuals with epilepsy undergoing pregnancy at the Maternal and Infant Health Programs at the University Health Network - Sinai Health and followed for epilepsy at the Toronto Western Hospital Epilepsy Clinic. In particular, we are interested in the association between following recommended epilepsy management guidelines for pregnant individuals with epilepsy and those aforementioned outcomes.

Official Title
-----------------
Obstetrical & Neurological Outcomes in Individuals With Epilepsy During Pregnancy

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WWE seen at the Toronto Western Hospital Epilepsy Clinic since June 1st 2022. Pregnant at any point between June 1st 2022 and June 1st 2024 (period of enrolment). Diagnosed with epilepsy as per the International League Against Epilepsy (ILAE) 2014 definition of epilepsy. Exclusion Criteria: None
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 |
| --- | --- | --- |
| Frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy | Describe the frequency of adherence to the 2015 Ontario Task Force management of epilepsy in pregnancy (i.e., AED regimen of WWE, frequency of polytherapy, adherence to serum monitoring of lamotrigine, and folic acid supplementation) and its association with year of pregnancy and type of healthcare provider. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical (neurological, obstetrical, neonatal) outcomes during pregnancy | To determine the association between adherence with the aforementioned guidelines and pregnancy, delivery, neonatal, and neurological outcomes when adjusting for baseline possible confounders. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Anti-seizure medication, Pregnancy, Neonatal, Obstetrical
Nevanimibe HCl for the Treatment of Classic CAH

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH). Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is anticipated that the overall duration of the study per subject will range from 24-42 weeks.

Official Title
-----------------
A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia

Conditions
-----------------
Congenital Adrenal Hyperplasia

Intervention / Treatment
-----------------
* Drug: Nevanimibe hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency and/or historical documentation of elevated 17-OHP Chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to screening Stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to screening and throughout the treatment period of the study Exclusion Criteria: Nonclassic CAH Other causes of adrenal insufficiency HIV, hepatitis B, or hepatitis C AST or ALT >2x ULN, bilirubin or serum creatinine >1.5x ULN

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nevanimibe hydrochloride<br>Ascending dose level of oral nevanimibe hydrochloride beginning with 500 mg BID up to 2000 mg BID | Drug: Nevanimibe hydrochloride<br>* During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving Serum 17-OHP Targets | The primary efficacy endpoint was the overall response rate within each cohort, defined as the percentage of patients achieving serum 17-OHP targets as follows: Men and postmenopausal women: 17-OHP ≤ 2x ULN Premenopausal women: Follicular phase: 17-OHP ≤ 2x follicular phase ULN Luteal phase: 17-OHP ≤ (2x follicular phase ULN + (luteal phase ULN - follicular phase ULN)) | Through Day 113 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAH, nevanimibe
Clinical Decision Support Algorithm to Predict Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Diabetic retinopathy (DR), a complication of diabetes, is a leading cause of blindness among working-aged adults globally. In its early stages, DR is symptomless, and can only be detected by an annual eye exam. Once the disease has progressed to the point where vision loss has occurred, the damage is irreversible. Consequently, early detection is quintessential in treating DR. Two barriers to early detection are poor patient compliance with the annual exam and lack of access to specialists in rural areas. This research is focused on developing and validating new, cost-effective predictive technologies that can improve early screening of DR. Our overall objective is to develop and implement an entire suite of tools to detect diabetes complications in order to augment care for underserved rural populations in the US and internationally.

Official Title
-----------------
Validating a Clinical Decision Support Algorithm Developed With Demographic, Co-morbidity, and Lab Data to Diagnose, Stage, Prevent, and Monitor a Patient's Diabetic Retinopathy

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Other: risk factors for diabetic retinopathy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For diabetic patients with DR: With 250.xx diabetes and 362.0x DR ICD-9 codes All variables are complete within the observation window For diabetic patients without DR: With 250.xx diabetes ICD-9 codes Without 362.0x DR ICD-9 codes All variables are complete within the observation window
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: risk factors for diabetic retinopathy|Demographic variables: gender, race, marital status, urban rural status. Co-morbidity variable: neuropathy, nephropathy, peripheral circulatory, ketoacidosis, hyperosmolarity Lab tests variables: alanine aminotransferase (ALT), albumin serum, anion gap, aspartate aminotransferase, blood urea nitrogen, calcium serum, chloride serum, creatinine serum, glucose serum plasma, hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), mean platelet volume (MPV), potassium serum, protein total serum, red blood cell (RBC) count, sodium serum, white blood cell (WBC) count|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetic retinopathy indicator (yes/no) | Diabetic patients with 362.0x ICD-9 codes are classified as DR patient | March, 2019 |
Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis

Study Overview
=================
Brief Summary
-----------------
A comparative analysis of glass ionomer sealant placed on permanent molars with and without a rubber dam to assess the retention over a 2 year period.

Detailed Description
-----------------
The purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. Pediatric patients (under <10 years of age) will receive a glass ionomer sealant on all four permanent first molars. One side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. Over a 2 year period, every 6 months the sealants will be assessed for retention. The glass ionomer sealant material will be Fuji Triage (GC America). The following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.

Official Title
-----------------
Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Device: Fuji Triage
* Other: isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects. - Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects, -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: each patient is serving as their own control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glass ionomer sealant<br>glass ionomer sealant | Other: isolation<br>* rubber dam or cotton roll isolation<br>|
| Experimental: isolation<br>isolation type either rubber dam or cotton roll isolation | Device: Fuji Triage<br>* glass ionomer sealant<br>* Other names: Fuji VII;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention rate of sealants | retention rate for sealants placed with different modes of isolation | 6 months |
Time Management in Nurse Anaesthetist Students

Study Overview
=================
Brief Summary
-----------------
Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia, has to work laboriously to cope with all assigned activities day and night. Time management, therefore, becomes a practical tool for nurse student to reach her goal. However, many factors act as barriers to nurse students' attaining and maintaining a high grade point average (GPA). Investigators would like to determine the effect of skills in time management on GPA amongst faculty nursing students.

Detailed Description
-----------------
Skills in time management are crucial for academic success. It can be defined as clusters of behavioural set that are essentials in the organisation of learning load. These are comprised of activities such as planning, prioritising, preparation, and following schedules. Consequently, it yields an impact on students' achievement. Nurse anaesthetist student is a registered nurse who spends 1- year training in anaesthesia. She has to work laboriously to cope with all assigned activities day and night. Time management, therefore, becomes a practical tool for nurse student to reach her goal. It has many good aspects; namely, problem analysis, target determination, planning, implementation, evaluation and revision for improvement . However, many factors act as barriers to nurse students' attaining and maintaining a high grade point average (GPA) at their training. Faculty members target all these issues in developing strategies to improve students' academic performance and learning achievement. As a result, time management would be a solution to solve these problems. Investigators would like to determine the effect of skills in time management on GPA amongst faculty nursing students. The research questions are as follows: What is the nurse student's competency on Time management? What is the relationship between GPA and Time management skills among faculty nursing students?

Official Title
-----------------
A Survey Study of Time Management in Nurse Anaesthetist Students

Conditions
-----------------
Educational Problems

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: volunteered nurse anaesthetist students in 1-year training program Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 36 Years

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

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 |
| --- | --- | --- |
| nurse student's competency on Time management | relationship between GPA and Time management skills among nurse students | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
time management, anaesthesia training program
Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness

Study Overview
=================
Brief Summary
-----------------
Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids. Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.

Official Title
-----------------
Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Montelukast (Singulair)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking adults with mild to moderate persistent asthma: FEV1 > 70 % pred PD20 methacholine < 3.9 mmol treated for at least 3 months with a stable dose of inhaled corticosteroids Documented dose-response plateau to inhaled methacholine on two occasions Males and non-pregnant females Exclusion Criteria: Asthma medication other than inhaled corticosteroids and inhaled b2-agonists Viral respiratory tract infections within the 3 weeks prior to enrollment

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>Oral montelukast 10 mg once daily for 12 weeks | Drug: Montelukast (Singulair)<br>* 10 mg tablet once daily<br>* Other names: Singulair;|
| Placebo Comparator: Placebo<br>Oral placebo once daily for 12 weeks | Drug: Placebo<br>* Oral placebo once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in maximal FEV1 decline at the dose-response plateau |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in PD20 methacholine |  | After 12 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Airway responsiveness, Dose-response plateau, Montelukast, Add-on to inhaled corticosteroids
Use of Topotecan in Patients With Refractory Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Detailed Description
-----------------
The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Official Title
-----------------
Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia

Conditions
-----------------
Non-Hodgkin's Lymphoma, Leukemia

Intervention / Treatment
-----------------
* Drug: Topotecan
* Drug: Mitozantrone
* Drug: Etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the following disease categories will be considered eligible for this study: Any acute leukemia beyond an initial attempt to induce a remission or after relapse Chronic Myelogenous Leukemia in Blast Phase Refractory Multiple Myeloma Refractory non-Hodgkin's and Hodgkin's Lymphoma Patients must be more than 14 days beyond prior myelotoxic chemotherapy Several other eligibility criteria apply. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: Arm 1<br> | Drug: Topotecan<br> <br> Drug: Mitozantrone<br> <br> Drug: Etoposide<br> <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
-----------------
Multiple Myeloma, Lymphoma, Leukemia, Etoposide, Drug Therapy, Clinical Trials
Linkage Study of Long QT Syndrome In An Amish Kindred

Study Overview
=================
Brief Summary
-----------------
To screen by electrocardiography the entire population of 1,400 individuals in seven Amish Mennonite communities in order to perform genetic linkage studies of long QT syndrome (LQTS).

Detailed Description
-----------------
BACKGROUND: LQTS is a severe heart disorder leading to sudden death due to ventricular tachycardia or ventricular fibrillation. The syndrome segregated as a Mendelian recessive in the highly inbred population under study and resulted in the sudden death of several members of the population. DESIGN NARRATIVE: The entire population was screened to identify cases of LQTS. In addition, 29 obligate heterozygotes were studied by 24-hour Holter monitoring to determine whether these gene carriers had any subtle phenotypes. The data were subjected to complex segregation and linkage analysis to establish the mode of inheritance and penetrance of LQTS. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Heart Diseases, Cardiovascular Diseases, Tachycardia, Ventricular, Ventricular Fibrillation, Long QT Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Biorepository of Biomarkers for Optimization of Microvascular Treatment of Lymphedema

Study Overview
=================
Brief Summary
-----------------
Researchers are collecting information, saliva, blood and tissue from subjects with lymphedema to store for future research.

Official Title
-----------------
Biorepository for Discovery and Validation of Biomarkers for Optimization of Microvascular Treatment of Lymphedema

Conditions
-----------------
Lymphedema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18+ years of age) Ability to provide written consent Has been diagnosed with Lymphedema Exclusion Criteria: Under the age of 18 years old Inability to provide written consent Previous lymphovenous bypass or lymph node transfer surgery Major changes occur to co-morbid conditions Proven ICG or iodine allergy

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 |
| --- | --- | --- |
| Biospecimen Acquisition | Number of biospecimens collected | 1 year |