linjc16/ctgov huggingface dataset:
ENT FiberLase CO2 Study

Study Overview
=================
Brief Summary
-----------------
This study is intended to collect data regarding treatment with a new flexible fiber used to transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study will include a single treatment that is performed transorally (through the mouth) for oral or laryngeal indications in the field of Ear, Nose and Throate (ENT).

Official Title
-----------------
ENT FiberLase CO2 Study

Conditions
-----------------
Laryngeal Diseases, Pharyngeal Diseases

Intervention / Treatment
-----------------
* Device: CO2 laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure. Adult Able and willing to comply with all visit, treatment and evaluation schedule and requirements Able to understand and provide written Informed Consent Disease which requires tissue ablation for treatment Exclusion Criteria: Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion); Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process Mentally incompetent, prisoner or evidence of active substance or alcohol abuse; Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: CO2 laser<br>* Ablation and coagulation of soft tissue<br>* Other names: Fiberlase Flexible Fiber;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to complete procedure with the study device | The number of interventions that were completed using the AcuPulse WG and FiberLase CO2 Fiber for the intended indication, without the need to revert to other means | Immediate - during intervention | 
| Complications (bleeding, perforation, damage to non target tissue) | Number of subjects with Adverse Events as a Measure of Safety | During intervention and up to 6 weeks following the procedure |
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)

Study Overview
=================
Brief Summary
-----------------
Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the cholesterol ester transfer protein (CETP), in healthy male subjects with high density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.

Detailed Description
-----------------
This open-label Phase 1 study will be conducted in three groups of 12 subjects with HDLc blood concentrations equal or below 80 mg/dl at a single study center. 36 subjects will be enrolled.

Official Title
-----------------
Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP), in Healthy Male Subjects With High Density Lipoprotein Cholesterol (HDLc) Blood Concentrations Equal or Below 80 mg/dl

Conditions
-----------------
HDL, Drug Safety

Intervention / Treatment
-----------------
* Biological: ATH03


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl Exclusion Criteria: Clinically relevant pathological findings

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATH03 Group A<br>ATH03, 10 µg, 0.2% Alum | Biological: ATH03<br>* 4 vaccinations<br>|
| Experimental: ATH03 Group B<br>ATH03, 30 µg, 0.2% Alum | Biological: ATH03<br>* 4 vaccinations<br>|
| Experimental: ATH03 Group C<br>ATH03, 100 µg, 0.2% Alum | Biological: ATH03<br>* 4 vaccinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 264 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity |  | 264 days | 
| Response to the various applied doses of ATH03 |  | 264 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CETP, Vaccine, Cholesterol, Inhibition
Effect of Biomagnetic Therapy on Gonarthrosis

Study Overview
=================
Brief Summary
-----------------
In order to assess the effectiveness of biomagnetic therapy (PST) in the treatment of gonarthrosis, we conducted a randomized, double blind controlled clinical trial comparing one group of patients treated with PST and a second group of patients treated with conventional physical therapy.

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Pulsed Signal Therapy (PST)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 35 years old local symptoms over a period of at least one-year persistent symptoms despite non steroidal anti-inflammatory drugs informed consent Exclusion Criteria: operative treatment in the last six months intra-articular injection in the last four months rheumatic disease homolateral coxarthrosis malignant disorder body mass index greater than 33% pregnancy inability to understand the visual analog scale

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulsed Signal Therapy (PST)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Official Title
-----------------
Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 ≤ age ≤ 45 Health Volunteers Subject who agreeds to participate in this clinical trial voluntarily Exclusion Criteria: 1. Subject who cannot participate in a clinical trial based on the PI's judgment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>CKD-828, D326, D337, CKD-F1, CKD-F2 | Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337<br>* Each arm has a different order for taking IP<br>|
| Experimental: Sequence B<br>CKD-828, D326, D337, CKD-F1, CKD-F2 | Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337<br>* Each arm has a different order for taking IP<br>|
| Experimental: Sequence C<br>CKD-828, D326, D337, CKD-F1, CKD-F2 | Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337<br>* Each arm has a different order for taking IP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration of the drug | 0 hour   144 hour | 
| AUCt | Area under the concentration-time curve from time zero to time | 0 hour   144 hour |
Genomic Investigation of Unusual Responders

Study Overview
=================
Brief Summary
-----------------
Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.

Official Title
-----------------
Genomic Investigation of Unusual Responders

Conditions
-----------------
Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer, Upper Aerodigestive Tract Cancer, Pancreatobiliary Gastrointestinal Cancer, Melanoma (Skin), Rare Cancer, Carcinoma of Unknown Primary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician. The exact definition of this is adaptable to the disease but a suggested guideline is a Complete Response, Partial Response or progression free interval of at least 6 months Exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death) The patient must have sufficient archival tumor available for sequencing. Deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements: a)) Patients who have archival tissue stored within the UHN Laboratory Medicine Program who have had a consent waiver granted by the REB to access the tissue. b) Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program Exclusion Criteria: None

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 |
| --- | --- | --- |
| Genomic Characterization of Tumor Samples | Characterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents. | Through study completion, up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Breast Cancer, Non- small Cell Lung Cancer, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer, Upper Aerodigestive Tract Cancer, Pancreatobiliary Gastrointestinal Cancer, Melanoma Cancer, Rare Cancer, Unknown Primary Cancer
Hypercoagulability After Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The risk of deep venous thrombosis after radical breast surgery is known. The objective of this study is to explore hypercoagulability after radical breast cancer surgery by studying several factors for haemostasis before, during and after surgery. Ultrasound Doppler examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen thrombin potential.

Official Title
-----------------
Plasma Coagulation Parameters and Hypercoagulability After Breast Cancer Surgery

Conditions
-----------------
Breast Cancer, Blood Coagulation Disorders

Intervention / Treatment
-----------------
* Procedure: Blood collection (pre and postoperative): plasma coagulation parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Breast cancer mastectomy Exclusion criteria: thrombophilia anticoagulant treatment

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood collection (pre and postoperative): plasma coagulation parameters|nan|

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
-----------------
Hypercoagulability, Plasma coagulation parameters, Breast cancer
Oral Curcumin Supplementation in Middle-Aged and Older Adults Improves Vascular Function

Study Overview
=================
Brief Summary
-----------------
The proposed study will assess the ability of curcumin, the active ingredient in the Indian spice tumeric, to improve the function of arteries with age. Overall, the proposed research project has the long-term potential to influence clinical practice guidelines by establishing a novel, easy to deliver, cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk of cardiovascular disease with age.

Official Title
-----------------
Clinical Translation of Curcumin Therapy to Treat Arterial Aging

Conditions
-----------------
Vascular Aging

Intervention / Treatment
-----------------
* Drug: Placebo pill
* Drug: High-dose curcumin pill
* Drug: Low-dose curcumin pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women must be postmenopausal body mass index (BMI) <40 kg/m2 weight stable in the prior 3 months absence of clinical disease as determined by medical history, physical examination, blood and urine chemistries, ankle-brachial index, and a graded exercise stress test with monitoring of blood pressure and 12-lead ECG

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 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: High-dose curcumin pill<br> | Drug: High-dose curcumin pill<br>* 2000mg curcumin pill/day<br>|
| Experimental: Low-dose curcumin pill<br> | Drug: Low-dose curcumin pill<br>* 500mg curcumin pill/day<br>|
| Placebo Comparator: Placebo pill<br> | Drug: Placebo pill<br>* sugar and other inert substances<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness | Arterial pulse wave velocity | 12 weeks | 
| Nitric-oxide mediated endothelium-dependent dilation | flow-mediated dilation and forearm blood flow responses to acetylcholine in the presence and absence of N'-monomethyl-L-arginine | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic oxidative stress and inflammation | circulating markers of oxidative stress and inflammation | 12 weeks | 
| Endothelial cell oxidative stress and inflammation | inflammatory and oxidative stress markers in biopsied vascular and arterial endothelial cells | 12 weeks |
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).

Study Overview
=================
Brief Summary
-----------------
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).

Official Title
-----------------
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria). Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy. Exclusion Criteria: Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years. Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib). Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Lumiracoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13. |  |  | 
| Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13. |  |  | 
| Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8. |  |  | 
| Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. |  |  | 
| Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13. |  |  | 
| Patient's health status using the Short Form-36 (SF-36), at week 13. |  |  | 
| Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, lumiracoxib, celecoxib, Cox-2
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Sildenafil is effective in the treatment of sustained pulmonary artery hypertension after corrected mitral valve disease.

Official Title
-----------------
Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease

Conditions
-----------------
Hypertension, Pulmonary, Diseases of Mitral Valve

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New York Heart Association Functional class (NYHA Fc) ≥ 2 dyspnea which was sustained till one year after the previous mitral valve surgery (repair or replacement) TR Vmax ≥ 3.5m/s by echocardiography Normal left ventricle ejection fraction (EF ≥ 50%) Pulmonary vascular resistance ≥ 3 Wood Unit or diastolic pressure gradient ≥ 7mmHg by cardiac catheterization Exclusion Criteria: Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation) Liver cirrhosis Chronic renal failure with serum creatinine ≥ 1.7mg/dL Lung disease (ex. chronic obstructive pulmonary disease, Asthma) Thyroid dysfunction Other causes which can lead to pulmonary hypertension
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil<br>Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year) | Drug: Sildenafil<br> <br> * Other names: Viagra, Revatio, others;|
| Placebo Comparator: Placebo<br>Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Six Minutes Walk Distance | unit of measure : meter (m) | baseline and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borg dyspnea score |  | six months | 
| Exercise capacity by cardiopulmonary exercise test |  | six months | 
| Fractional area change of right ventricle measured by echocardiography | unit of measure : percent (%) | six months | 
| Pulmonary vascular resistance (PVR) measured by cardiac catheterization | unit of measure : wood unit (WU) | six months | 
| Systolic pulmonary artery pressure measured by cardiac catheterization | unit of measure : pressure (mmHg) | six months | 
| Mean pulmonary artery pressure measured by cardiac catheterization | unit of measure : pressure (mmHg) | six months |