linjc16/ctgov huggingface dataset:
Treatment of Moderate to Severe Lateral Canthal Lines

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines

Conditions
-----------------
Lateral Canthal Lines

Intervention / Treatment
-----------------
* Biological: botulinum toxin
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older. Moderate to severe LCL at maximum smile as assessed by the Investigator. Moderate to severe LCL at maximum smile as assessed by the subject. Exclusion Criteria: Previous use of any Botulinum toxin treatment in facial areas within 9 months prior to study treatment. Female who is pregnant, breast feeding, or intends to conceive a child during the study. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection | Biological: botulinum toxin<br>* neuromodulator<br>* Other names: QM1114-DP;|
| Placebo Comparator: Placebo<br>A buffered solution; Mode of administration: intramuscular injection | Biological: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month. | The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe) | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. |  | One Month |
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the reliability of a shortened fat tolerance test (abbreviated fat tolerance test, or AFTT) for measuring post-meal lipids in human blood. The reliability of the triglyceride results in this test are compared to the reliability of the glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically accepted metabolic test.

Official Title
-----------------
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test

Conditions
-----------------
Dyslipidemias, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: High-fat shake
* Other: Pure glucose solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free of chronic disease Normal (healthy) fasting glucose and triglycerides Exclusion Criteria: Presence of pace-maker Pregnant Using tobacco products Using medications or dietary supplements that could modify primary outcomes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abbreviated Fat Tolerance Test<br> | Other: High-fat shake<br>* Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.<br>|
| Active Comparator: Oral Glucose Tolerance Test<br> | Other: Pure glucose solution<br>* Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of the Change in Triglycerides after a High-Fat Meal | Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined. | The two fat tolerance tests are separated by 1 week. | 
| Reliability of the Change in Glucose after Ingestion of a Glucose Solution | Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined. | The two glucose tolerance tests are separated by 1 week. |
Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.

Official Title
-----------------
Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities Exclusion Criteria: locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 3DCRT group<br>In this plan, we will create plans using three dimensional conformal radiotherapy, evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. | |
| IMRT group<br>In this plan, we will create plans using intensity modulated radiotherapy (IMRT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. | |
| VMAT plan<br>In this plan, we will create plans using volumetric modulated radiotherapy (VMAT), evaluate organs at risk doses, dose homogeneity and planned target volume coverage. Then compare these parameters with the two other plans. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of coverage of planned target volume(PTV) among the three plans. | PTV coverage in dose is compared among the three plans. | 1 year | 
| Comparison of doses to organs at risk among the three plans. | mean dose of the heart, lung volume receiving 20Gy, esophageal doses will be compared among the three plans | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of target homogeneity among the three plans. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
computer assisted, radiotherapy
Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide

Study Overview
=================
Brief Summary
-----------------
Prospective, observational pilot study of ten post-transplant patients presenting with diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once the diagnosis is confirmed, the patients will then be treated with a short course of subcutaneous Octreotide which has been shown to cure this type of diarrhea.

Official Title
-----------------
Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide

Conditions
-----------------
Diarrhea, Immunosuppression

Intervention / Treatment
-----------------
* Drug: Octreotide Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients between the ages of 18 and 75 years old who are solid organ transplant recipients followed at Toronto General Hospital on MMF referred to gastroenterology for diarrhea. Exclusion Criteria: Subjects with a known history of IBD or GVHD of the bowel. Any subject receiving Octreotide for another indication. Any patient unable to undergo endoscopy. Any patient with a contraindication to Octreotide therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Diarrhea on MMF<br>Solid organ transplant recipients on MMF who develop diarrhea while taking the drug. Fecal calprotectin will be measured in their stool and Octreotide Acetate will be used to treat their diarrhea. | Drug: Octreotide Acetate<br>* Octreotide 100mcg SC q12h for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Fecal Calprotectin levels patients with diarrhea on MMF |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of patients with MMF induced diarrhea with Octreotide |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diarrhea, Immunosuppression, Post-transplantation, Octreotide, Mycophenolate Mofetil, Fecal Calprotectin
Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.

Conditions
-----------------
Labour Induction

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Dinoprostone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primigravida >37 wks Exclusion Criteria: Scarred uterus Macrosomia
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol<br>oral misoprostol in solution 25 microgram every 2 hours | Drug: Misoprostol<br> <br> |
| Active Comparator: dinoprostone<br>3 mgs dinoprostone vaginally every six hours | Drug: Dinoprostone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction delivery time |  | 2 hourly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labour, induction, misoprostol, dinoprostone
QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Study Overview
=================
Brief Summary
-----------------
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).

Detailed Description
-----------------
Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.

Official Title
-----------------
Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Glaucoma surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria: all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression patients not tolerating antiglaucoma medications, patients with poor compliance progression in visual field Exclusion Criteria: active inflammatory disease pregnancy mental disease or emotional instability general steroid therapy inability to fill in the questionnaire

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: traditional glaucoma surgery<br>glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy | Procedure: Glaucoma surgery<br>* phacoemulsification<br>* Other names: cataract surgery when required;|
| Active Comparator: microinvasive glaucoma surgery (MIGS)<br>glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device | Procedure: Glaucoma surgery<br>* phacoemulsification<br>* Other names: cataract surgery when required;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEI VFQ 25 quality of life score change | NEI VFQ 25 baseline and 3 months after surgery | baseline (0-30 days; pre-operative) and three months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL, quality of life, NEI VFQ 25
Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
Check whether patients with higher comorbidity and risk of complication, estimated using the V (p) -POSSUM score, ACS NSQIP and the ASA classification, present higher baseline activated clotting time values.

Official Title
-----------------
Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery

Conditions
-----------------
Artery Disease, Peripheral, Aortic Diseases, Carotid Artery Diseases, Other Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Activated clotting time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing vascular surgery requiring intraoperative heparinization Exclusion Criteria: Pregnant women SARS-CoV-2 PCR positive (performed 24-72h prior to surgery) Severe plaquetopenia <50,000

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 |
| --- |
|Diagnostic Test: Activated clotting time|Relationship between elongated baseline activated clotting time and comorbidity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on baseline Activated Clotting Time with comorbidities | Activted Clotting Time will be measured with Haemocron Machine just before surgery. Comorbidities will be measured with V(p)Possum, AC NSQUIP and ASA scales. | 1 day - surgery day |
Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the BFM treatment strategy

Detailed Description
-----------------
The study enrols children from 8 participating organizations. All children are treated with similar protocols based on the BFM treatment strategy, which include induction, consolidation, reinduction and continuation-therapy phases. At the beginning of the continuation-therapy phase, those patients in complete remission are randomly assigned to either a treatment or a control group. Control patients are given conventional mercaptopurine and methotrexate chemotherapy only. Patients in the treatment arm are also given pulses of vincristine (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.

Official Title
-----------------
Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: vincristine
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age <1 or >5 years or white blood cell count at diagnosis >=20000 Exclusion Criteria: prednisone poor response no complete remission at the end of induction (IA) t(9,22) clonal translocation t(4,11) clonal translocation

Ages Eligible for Study
-----------------
Maximum Age: 17 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

| Intervention/Treatment |
| --- |
|Drug: vincristine|nan|
|Drug: dexamethasone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute lymphoblastic leukemia, maintenance, BFM protocol, intermediate risk childhood acute lymphoblastic leukemia
Resistant Arterial Hypertension Cohort Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the epidemiology of resistant hypertension, evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the randomization of two doses of the diuretic used - chlorthalidone), study two interventions in the group of patients that is non-compliant, and study environmental and genetic variables of individuals with resistant hypertension in a family design.

Official Title
-----------------
Interventional Prospective Cohort Study, Multi-center With Nested Case-control Studies (Family-based and Non-family Based) on Individuals With Resistant Arterial Hypertension.

Conditions
-----------------
Hypertension, Essential Hypertension, Resistant Hypertension

Intervention / Treatment
-----------------
* Drug: chlorthalidone
* Behavioral: motivational intervention for non-compliant individuals
* Drug: standardized anti-hypertensive treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent resistant hypertension at the moment of inclusion 18 years or more, both sexes are included women at reproductive age: consenting to use oral contraception Exclusion Criteria: patients mentally impaired or unable to give informed consent patients speaking only a foreign language other than French, German, or English patients living far away, making the study visits not practical

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 |
| --- | --- |
| chlorthalidone<br> | Drug: chlorthalidone<br>* chlorthalidone 25mg/d vs. chlorthalidone 50mg/d<br>|
| motivational invervention<br>motivational interview(s) vs. repeated calls vs. no particular intervention | Behavioral: motivational intervention for non-compliant individuals<br>* motivational interview(s) vs. repeated calls vs. no particular intervention<br>|
| standardized anti-hypertensive treatment<br> | Drug: standardized anti-hypertensive treatment<br>* olmesartan, amlodipine, chlorthalidone, +- spironolactone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure control |  | at 12 weeks after initiation of standard treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular morbidity and mortality | additional secondary: BP control at yearly follow-up | 5 years |